FDA Medical Device Recalls (openFDA)
Staar Surgical Co.: STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
- Recall number
- Z-1964-2016
- Recalling firm
- Staar Surgical Co.
- Product
- STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
- Status
- Terminated
- Initiated
- 2016-05-02
- Posted
- not on file
- Terminated
- 2016-11-15
- Reason
- The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).
- Root cause
- Process control
- Action
- STAAR sent a Medical Device Recall Letter dated May 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STAAR Surgical is recalling the STAAR AQ Cartridge-FP because it may malfunction and may crack during loading or delivery of the IOL. Customers with questions are instructed to contact their STAAR customer service representative at (800) 352-7842.
- Quantity
- 2,612 units
- Distribution
- US
- Lot, serial or model codes
- 1281706, 1282812
- 510(k) numbers
- ["K940593"]
- PMA numbers
- not on file
- Product code
- KYB
- Firm FEI
- 2023826
- Firm city
- Monrovia
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28