FDA Medical Device Recalls (openFDA)
Aaren Scientific, Incorporated: Precision Aspheric Lens (PAL) Intraocular Lens Model: EC-3 PAL, Serial Number: 1169381106, 1169391106, 1169421106 The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
- Recall number
- Z-1077-2012
- Recalling firm
- Aaren Scientific, Incorporated
- Product
- Precision Aspheric Lens (PAL) Intraocular Lens Model: EC-3 PAL, Serial Number: 1169381106, 1169391106, 1169421106 The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
- Status
- Terminated
- Initiated
- 2011-08-02
- Posted
- 2012-02-22
- Terminated
- 2012-08-10
- Reason
- The recall was initiated because Aaren Scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.
- Root cause
- Incorrect or no expiration date
- Action
- Aaren Scientific sent a recall communication letter dated August 2, 2011, August 3, 2011, and August 30, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Aaren Scientific is requesting that you return the lenses and we will rework the product and return them back to you. Please let me know and I will issue an RGA number and inform you of our FedEx account number to reference. In the meantime, we are conducting an internal investigation regarding this issue. Once this has been closed out then we will notify you of our findings. For further questions please call (909) 937-1033 ext. 108.
- Quantity
- 3 units
- Distribution
- Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon.
- Lot, serial or model codes
- Lot Number: 110617
- 510(k) numbers
- not on file
- PMA numbers
- ["P100016"]
- Product code
- HQL
- Firm FEI
- 3013202565
- Firm city
- Ontario
- 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