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HomeAlcon Laboratories, Inc. › A.C.S® (Alcon Closure System)

A.C.S® (Alcon Closure System)

Alcon Laboratories, Inc. · Model 8065217601 · UDI-DI 00380652176019

GAS Prescription
10
510(k) clearances
825
Adverse events (9 deaths)
1
Recalls
43
Facilities

Description

Suture - Needle Type PC-7,Green Monofilament Polyester(GMP), Suture Size 10-0, Suture Length 8,Double Armed

Recalls

DateFirmReason
2013-05-03Surgical Instrument Service And Savings, Inc.The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.