Johnson & Johnson Surgical Vision, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 9 510(k) filings: 0 Recalls: 1

Known Identifiers & Locations

FEI Numbers 2648035, 3003843509, 3004178847, 3004651700, 3004750704, 3005675890, 3006695864, 3008169506, 3011714173, 3012236936
Owner Operator Numbers 10053607
Locations Covered ANASCO, PR, US; GRONINGEN, NL; HANGZHOU Zhejiang, CN; Hangzhou Zhejiang, CN; Irvine, CA, US; Milpitas, CA, US; UPPSALA, SE

Registered Establishments (9)

Registration # Establishment Name Location Establishment Type(s) Action
2648035 AMO PUERTO RICO MANUFACTURING, INC ANASCO, PR, US Manufacture Medical Device View Details
3004178847 AMO (HANGZHOU) CO., LTD. HANGZHOU Zhejiang, CN Manufacture Medical Device View Details
3004750704 AMO UPPSALA AB UPPSALA, SE Manufacture Medical Device View Details
3005675890 OptiMedica Corp. Milpitas, CA, US Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
3006695864 AMO Manufacturing USA, LLC Milpitas, CA, US Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
3008169506 TearScience, Inc. Milpitas, CA, US Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
3011714173 AMO (HANGZHOU PARK) WAREHOUSE Hangzhou Zhejiang, CN Export Device to the United States But Perform No Other Operation on Device View Details
3012236936 Johnson & Johnson Surgical Vision, Inc. Irvine, CA, US Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
9614546 AMO GRONINGEN BV GRONINGEN, NL Manufacture Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall # Product Description Initiation Date Status Action
Z-0028-2022 TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery. Reason: Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance. 2021-08-06 Terminated View Details

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