InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid en
FDA device recall Z-1888-2024 · posted 2024-05-23 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Potential for distal end of the sheath to break off during a procedure.
- Action taken
- Consignees were mailed an URGENT MEDICAL DEVICE CORRECTION notification, dated 5/1/24. Consignees are instructed to read the provided labeling addendum, inspect their inventory to identify affected devices and place a copy of the addendum with the remaining inventory, ensure all required personnel are aware of this recall, notify those who received product further distributed, and acknowledge receipt of the recall notification using Olympus's recall portal. Consignees can report the incidence of a device breakage associated with this event to the Technical Assistance Center at 1-800-8489024, Option 1. Consignees with any questions can contact Olympus at 647-999-3203 or by email at Cynthia.Ow@olympus.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- EOB
- Quantity affected
- pending
- Distribution
- Domestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.
- Date initiated
- 2024-04-03
- Date posted
- 2024-05-23
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| InstaClear Lens Cleaner (K152531) | Gyrus Acmi, Inc. | 2016-01-15 |