FDA Device Recall Z-0099-2024: Alcon Research, LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0099-2024.

Recall Res Number

Z-0099-2024

Recalling Firm / Manufacturer

Alcon Research, LLC

FEI Number

1000125771

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2023-08-18

Date Posted

2023-10-11

Date Terminated

N/A

Product Code

HQC

Event Number

93010

Product Quantity

Product Description Constellation Vision System, REF: 8065751150

Reason for Recall Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.

Action Details Starting on 8/18/23, Field Service Engineers told customers their devices needed pneumatics module replacements, and this replacement activity was subsequently completed. On 9/29/23, correction notices were mailed to customers informing them vision systems were corrected and asking they complete and return the response form to Market.Actions@Alcon.com Should you have any questions or concerns call Customer Service at 1-800-862-5266.

Distribution Pattern US: GA, IL, PR

Code Information / Serial Numbers UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X

Related Establishments / Registrations

Sterigenics U.S., LLC Registration: 1036836 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
Bausch & Lomb Incorporated Registration: 1313525 View Registration
HARMAC MEDICAL PRODUCTS, INC. Registration: 1317547 View Registration
Viant AS&O Holdings, LLC Registration: 1319429 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1319660 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
ISOMEDIX OPERATIONS INC Registration: 1526711 View Registration
Alcon Research, LLC Registration: 1644019 View Registration
Sterigenics US LLC Registration: 1649518 View Registration
Isomedix Operations Inc. Registration: 1650907 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
ZEVEX, INC. Registration: 1722139 View Registration
Bausch & Lomb Incorporated Registration: 1920664 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
Bausch & Lomb Incorporated Registration: 1932180 View Registration
SYNERGETICS, INC. Registration: 1932402 View Registration
MEDICAL TECHNICAL PRODUCTS, INC Registration: 2025303 View Registration
Alcon Research, LLC Registration: 2028159 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
Isomedix Operations, Inc Registration: 2032098 View Registration
MED-LOGICS, INC. Registration: 2085081 View Registration
Lake Region Medical Registration: 2126666 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
Alcon Research, LLC Registration: 2523835 View Registration
Peregrine Surgical, LLC. Registration: 2529392 View Registration
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. Registration: 2935428 View Registration
Sterigenics Germany GmbH Registration: 3002807090 View Registration
Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre Registration: 3003365815 View Registration
ALCON GRIESHABER AG Registration: 3003398873 View Registration
MODO INC Registration: 3004636440 View Registration
MIDWEST STERILIZATION CORP. Registration: 3005012805 View Registration
Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
AMO Manufacturing USA, LLC Registration: 3006695864 View Registration
MEDISTRI SA Registration: 3006946276 View Registration
Sterigenics Shanghai ETO Ltd. Registration: 3007007790 View Registration
Flextronics Manufacturing Juarez S. DE R.L. DE C.V. Registration: 3007344957 View Registration
TECHNOLAS PERFECT VISION GMBH Registration: 3007606649 View Registration
ABA Medical Technology Co Ltd Registration: 3007648309 View Registration
Sanmina Registration: 3007867838 View Registration
Synergy Health Radeberg GMBH Registration: 3008102042 View Registration
RM Healthcare Products SA de CV Registration: 3008692839 View Registration
LENSAR, Inc Registration: 3009026057 View Registration
Synergy Health Ede BV Registration: 3009337401 View Registration
BGS BETA-GAMMA-SERVICE GMBH & CO KG Registration: 3009732568 View Registration
AUTOCAM MEDICAL Registration: 3010047402 View Registration
Synergy Health Allershausen GmbH Registration: 3010160527 View Registration
PROVIDENCE ENTERPRISE LIMITED Registration: 3010162782 View Registration
Alcon Research, LLC Registration: 3010208880 View Registration
Synergy Sterilisation (M) Sdn Bhd Registration: 3010220595 View Registration
AvailMed S.A.De C.V. Registration: 3010291427 View Registration
Carl Zeiss Meditec Cataract Technology Inc Registration: 3012123033 View Registration
UNIVAC PRECISION ENGINEERING PTE LTD Registration: 3012132406 View Registration
Johnson & Johnson Surgical Vision, Inc. Registration: 3012236936 View Registration
Alcon Research, LLC Registration: 3013497605 View Registration
Modo, Inc. Registration: 3013875599 View Registration
SAINT-GOBAIN PERFORMANCE PLASTICS Registration: 3014256632 View Registration
Alcon Laboratories Belgium Registration: 3015456951 View Registration
RAICO Registration: 3015528097 View Registration
NPA de Mexico S.de R.L. de C.V. Registration: 3016245399 View Registration
MICROSURGICAL TECHNOLOGY, INC. Registration: 3019924 View Registration
MANUFACTURAS Y SERVICIOS INTERNACIONALES, S. DE R.L. Registration: 3029973819 View Registration
Bausch & Lomb Incorporated Registration: 3029990829 View Registration
ALCON GRIESHABER AG Registration: 3033485955 View Registration
THIS AG Registration: 3042928348 View Registration
Strub Medical GmbH & Co. KG Registration: 8010510 View Registration
OERTLI INSTRUMENTE AG Registration: 8030967 View Registration
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. Registration: 9611516 View Registration
CARL ZEISS MEDITEC AG (OBERKOCHEN) Registration: 9615010 View Registration
PT. CIBA VISION BATAM Registration: 9681121 View Registration
Coastline de Mexico SA de CV Registration: 9681572 View Registration

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Medical Device Recall: Z-0099-2024

Recall Parameters & Description

Related Establishments / Registrations

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