# P990013: Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens

- Pathway: PMA
- Applicant: Starr Surgical Co.
- Decided: Apr 2, 2000 after 394 days
- Product code: HQL (Intraocular Lens)
- Device class: 3
- Regulation: 21 CFR 886.3600
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jun 10, 2013 · Class II · Z-1747-2013: STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.
- Jun 10, 2013 · Class II · Z-1746-2013: STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.
- May 20, 2011 · Not classified · Z-2706-2011: 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 
- Jun 17, 2004 · Not classified · Z-1037-04: Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number.
- Feb 9, 2004 · Not classified · Z-0539-04: Risk of hyperopic refractive changes.

Source page: https://510kreport.com/device/P990013
Methodology: https://510kreport.com/methodology