Collamer UV One-Piece IntraOcular Lens recallZ-0539-04 · Staar Surgical Co Inc · initiated Feb 9, 2004
Terminated All recalls posted in February 2004
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 Inc 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
Risk of hyperopic refractive changes.
FDA root cause category: Other
What the company is doing
Firm is distributing letters to physicians suggesting ways to mitigate the observed contracture of the eye tissues after implantation. Letters will be sent 2/9/2004.
Recall details
- Recall number
- Z-0539-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 9, 2004
- Posted by the FDA
- Feb 18, 2004
- Recalling firm
- Staar Surgical Co Inc
- Quantity
- No quantity applies.
- Product code
- HQL
- FDA submissions
- P990013
- Distribution
- Nationwide and to Australia, Canada, Chile, France, Germany, India, Lebanon, South Africa, Switzerland, United Kingdom.
Product description
Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF
Code information (models, lots, serial numbers)
No codes apply
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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