Device product
BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.
Z-0161-2023
Product summary
- Event
- Event 90946
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 708 kits
- Official record key
device-enforcement:Z-0161-2023
Official wording
Reason: Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Code information: GTIN (01) 10195327108168, Lot Number 22DBL466
Distribution pattern: US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
Derived failure modes
-
Unknown
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.