Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542102063)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542102063), received between Oct 23, 2018 and Oct 4, 2019 — classified as 2 malfunctions.

5 other recalls cover devices cleared under the same FDA submission (P990013); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON 16/MAY/2019 A CQ2015A, +24.0 DIOPTER, INTRAOCULAR LENS TORE DURING INJECTION INTO THE EYE. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS WAS REMOVED AND EXCHANGED DURING INITIAL SURGERY AND THIS RESOLVED THE PROBLEM. PER THE REPORTER ON 03/OCT/2019 THE EVENT WAS NOT PRODUCT RELATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9157478 ↗
• MalfunctionOct 23, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CQ2015A, +24.0 DIOPTER, INTRAOCULAR LENS WAS DAMAGED DURING THE INSERTION, THE OPTIC WAS TORN. THERE WAS PATIENT CONTACT BUT NO INJURY. CAUSE OF DAMAGE IS UNKNOWN. THE LENS WAS REMOVED AND REPLACED WITH THE SAME DIOPTER AND MODEL DURING INITIAL SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7994772 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990013. One submission often covers many models, so check the product and lot details in each record.

• Z-1747-2013 · Jun 10, 2013 · Terminated
  Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
• Z-1746-2013 · Jun 10, 2013 · Terminated
  nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implante
• Z-2706-2011 · May 20, 2011 · Terminated
  Brand Name STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens Common Names Collamer single piece IOL Collamer plate haptic IOL
• Z-1037-04 · Jun 17, 2004 · Terminated
  STAAR Surgical Intra Occular Lens, Collamer.
• Z-0539-04 · Feb 9, 2004 · Terminated
  Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF