Brand Name recallZ-2706-2011 · Staar Surgical Co. · initiated May 20, 2011
Terminated All recalls posted in June 2011
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Staar Surgical Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- 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 by Staar Surgical due to an error in the Directions for Use (DFU) for Staar Surgical's Collamer Ultraviolet Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens (Collamer IP IOL), also known as the nanoFLEX IOL. The Device Description erroneously indicates that the lens could be implanted in the ciliary sulcus.
FDA root cause category: Other
What the company is doing
Staar Surgical send out an URGENT - Medical Device Correction Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to acknowledge receipt of the letter by signing, dating, and faxing the form to Staar Surgical. For any questions call (800) 292-7902, ext 2345.
Recall details
- Recall number
- Z-2706-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 20, 2011
- Posted by the FDA
- Jun 29, 2011
- Recalling firm
- Staar Surgical Co.
- Quantity
- 16,750 devices distributed to the field
- Product code
- HQL
- FDA submissions
- P990013
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of South Africa, Slovakia, Mexico, Hong Kong, and Sri Lanka
Product description
Brand Name STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens Common Names Collamer single piece IOL Collamer plate haptic IOL The Device is intended to correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The Device is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).
Code information (models, lots, serial numbers)
CC4204BF and CC4204A
Other devices under the same FDA submission
60 devices cleared under P990013 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204AStaar Surgical Company · Intraocular Lens25 reports
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204AStaar Surgical Company · Intraocular Lens22 reports
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204AStaar Surgical Company · Intraocular Lens20 reports
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204AStaar Surgical Company · Intraocular Lens20 reports
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204AStaar Surgical Company · Intraocular Lens18 reports
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204AStaar Surgical Company · Intraocular Lens18 reports
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204AStaar Surgical Company · Intraocular Lens17 reports
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204AStaar Surgical Company · Intraocular Lens17 reports
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204AStaar Surgical Company · Intraocular Lens16 reports
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015AStaar Surgical Company · Intraocular Lens15 reports
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015AStaar Surgical Company · Intraocular Lens13 reports
- Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015AStaar Surgical Company · Intraocular Lens12 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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