Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542101929)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542101929), received between Sep 26, 2019 and Sep 27, 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.

• MalfunctionSep 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A CQ2015A COLLAMER THREE PIECE LENS, +17.0 DIOPTER, WAS INSERTED AND REMOVED FROM THE PATIENTS LEFT EYE (OS), DURING THE SAME SURGERY DUE TO THE SURGEON WAS UNABLE TO GET THE 2ND HAPTIC TO GO INTO THE SULCUS. THE LENS WAS CUT INTO 2 PIECES TO REMOVE WITH NO PATIENT INJURY. THIS IS THE 2ND OF 2 LENSES USED FOR THIS PATIENT THAT THE SURGEON WAS UNABLE TO GET THE 2ND HAPTIC TO GO INTO THE SULCUS - SEE MFR REPORT # 2023826-2019-01748 FOR 1ST LENS. A 3RD COLLAMER THREE PIECE LENS WAS IMPLANTED SUCCESSFULLY AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131777 ↗
• MalfunctionSep 26, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A CQ2015A COLLAMER THREE PIECE LENS, +17.0 DIOPTER, WAS INSERTED AND REMOVED FROM THE PATIENTS LEFT EYE (OS), DURING THE SAME SURGERY DUE TO THE SURGEON WAS UNABLE TO GET THE 2ND HAPTIC TO GO INTO THE SULCUS. THE LENS WAS CUT INTO 2 PIECES TO REMOVE WITH NO PATIENT INJURY. A 2ND LENS WAS INSERTED BUT THE SURGEON WAS UNABLE TO GET THE 2ND HAPTIC TO GO INTO THE SULCUS - SEE MFR REPORT # 2023826-2019-01749 FOR 2ND LENS. A 3RD COLLAMER THREE PIECE LENS WAS IMPLANTED SUCCESSFULLY AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126527 ↗

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