STAAR Surgical Intra Occular Lens, Collamer recallZ-1037-04 · Staar Surgical Co Inc · initiated Jun 17, 2004
Terminated All recalls posted in July 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
Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number.
FDA root cause category: Other
What the company is doing
Consignees are being notified to check their inventory for mismatching labels. Notifications were sent June 17 to all customers.
Recall details
- Recall number
- Z-1037-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 17, 2004
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- Staar Surgical Co Inc
- Quantity
- Not specified.
- Product code
- HQL
- FDA submissions
- P990013
- Distribution
- Nationwide.
Product description
STAAR Surgical Intra Occular Lens, Collamer.
Code information (models, lots, serial numbers)
All lenses packaged weeks of 9-13 and 23-27 February.
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.
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- 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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