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Intraocular Lens (IOL) recallZ-1076-2012 · Aaren Scientific, Incorporated · initiated Aug 2, 2011

Terminated All recalls posted in February 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Aaren Scientific, Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Incorrect or no expiration date

What the company is doing

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.

Recall details

Recall number
Z-1076-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 2, 2011
Posted by the FDA
Feb 22, 2012
Recalling firm
Aaren Scientific, Incorporated
Quantity
3 units
Product code
HQL
FDA submissions
P100016
Distribution
Worldwide Distribution - USA including CA and TN, and the countries of India and Lebanon.

Product description

Intraocular Lens (IOL). Model: EC-3, Serial Number: 1169371106, 1169401106, 1169471106 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.

Code information (models, lots, serial numbers)

Lot Number: 110617

Other devices under the same FDA submission

48 devices cleared under P100016 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 60962).

Sources and updates

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