Device product
BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS Catalog #585278
Z-1626-2022
Product summary
- Event
- Event 90336
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 Box
- Official record key
device-enforcement:Z-1626-2022
Official wording
Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Code information: GTIN: 30886158002995; 00886158002994 EA
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.