FDA Device Recall Z-2066-2017: Abbott Medical Optics Inc. (AMO)

Recall Parameters & Description

Normalized public record details for FDA recall code Z-2066-2017.

Recall Res Number

Z-2066-2017

Recalling Firm / Manufacturer

Abbott Medical Optics Inc. (AMO)

FEI Number

3003843509

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2017-04-01

Date Posted

N/A

Date Terminated

2017-11-27

Product Code

LZP

Event Number

77023

Product Quantity

293,867 units total

Product Description Healon Pro, Part No. 10270012

Reason for Recall Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.

Action Details A recall letter was sent to customers on 4/1/17 to inform them that AMO has voluntarily initiated this Action because a remote possibility exists that certain Healon OVD solutions in the affected lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. Use of OVD solutions with glass particles could potentially lead to intraocular injury. Customers are instructed to complete the Customer Reply Form and fax it to AMO Quality Assurance at 714-247-4510 or email to RegCompliOne@abbott.com within 3 business days of receipt of the letter. Customers with product complaints or adverse events are instructed to inform AMO by calling 877-266-4543. Customers that do report a complaint are instructed to provide the Healon OVD lot number and, if a patient was involved, the date of surgery, a description of the event and patient outcome.

Distribution Pattern US and worldwide: Austria Belgium Croatia Czech Republic Denmark Finland France Germany Great Britain Iceland Ireland Israel Italy Latvia Lebanon Lithuania Netherlands Norway Portugal Spain Sweden Switzerland Tunisia Turkey Russian Fed Guadeloupe Sri Lanka Australia China Hong Kong Indonesia Malaysia Singapore South Korea Taiwan Thailand Japan Chile Colombia Costa Rica Ecuador

Code Information / Serial Numbers UB32524

Related Establishments / Registrations

U.S. IOL, INC. Registration: 1037089 View Registration
EYEKON MEDICAL, INC. Registration: 1038833 View Registration
VISIONARY MEDICAL SUPPLIES, INC. Registration: 1064514 View Registration
Bausch & Lomb Incorporated Registration: 1119279 View Registration
Beaver-Visitec International, Inc. Registration: 1211998 View Registration
Bausch & Lomb Incorporated Registration: 1313525 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
Alcon Research, LLC Registration: 1610287 View Registration
OASIS MEDICAL, INC. Registration: 2083373 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
LIFECORE BIOMEDICAL LLC Registration: 2184002 View Registration
CIMA TECHNOLOGY, INC. Registration: 2529709 View Registration
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. Registration: 3000164186 View Registration
Novartis Manufacturing NV Registration: 3002037047 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
AMO UPPSALA AB Registration: 3004750704 View Registration
Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
ANIKA THERAPEUTICS, INC. Registration: 3007093114 View Registration
Synergy Health Ede BV Registration: 3009337401 View Registration
Nordic Pharma, Inc. Registration: 3011965331 View Registration
Johnson & Johnson Surgical Vision, Inc. Registration: 3012236936 View Registration
Alcon Laboratories Belgium Registration: 3015456951 View Registration
Nordic Pharma BVG Registration: 3039186269 View Registration
AUROLAB Registration: 9710098 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-2066-2017

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer