Device product
OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
Z-0708-2022
Product summary
- Firm
- Lacrimedics Inc
- Event
- Event 89463
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5767 units
- Official record key
device-enforcement:Z-0708-2022
Official wording
Reason: The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.
Code information: HP3 010819-3104 HP3 011321-3373 HP3 031519-3128 HP3 032521-3426 HP3 051419-3157 HP3 073118-3044 HP3 090921-3516 HP3 102618-3060 HP5 011221-3374 HP5 012519-3088 HP5 032019-3123 HP5 032621-3425 HP5 051519-3158 HP5 062521-3489 HP5 070819-3186 HP5 072221-3501 HP5 083018-3036 HP5 102918-3061 HP5 122120-3368 HP7 030821-3404 HP7 032119-3124 HP7 092019-3135 HP7 103018-3062
Distribution pattern: Nationwide and Worldwide Distribution to following countries - AR. BE, BO, BR, CH, CN, CO, CZ, DE, EC, ES, FI, GE, IN, IL, MY, MX, NZ, PE, RO, SG, SA, TR, TW, TZ, UK
Derived failure modes
-
Labeling or packaging
pouch seal may contain channels that could affect the seal integrity and potentially compromise
-
Sterility assurance
sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise