Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542101837)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542101837), received between Dec 20, 2016 and Jun 8, 2017 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A MICL12.6, -8.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT REPORTED EXPERIENCING GLARES AND HALOS. THE LENS CURRENTLY REMAINS IMPLANTED BUT THE DOCTOR IS PLANNING TO EXPLANT THE LENS. THE PATIENT'S NEXT VISIT IS SCHEDULED ON (B)(6) 2017 AND THE DOCTOR WILL SCHEDULE THE SURGERY DATE TO EXPLANT THE LENS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6625059 ↗
• MalfunctionJan 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON ATTEMPTED TO INSERT A (B)(4) COLLAMER THREE PIECE LENS, +12.5 DIOPTER, AND THE LENS WAS DAMAGED. THERE WAS PATIENT CONTACT BUT NO INJURY AND ANOTHER SAME MODEL/DIOPTER LENS WAS IMPLANTED. THE REPORTER INDICATED THE CAUSE OF THE LENS DAMAGE WAS DUE TO THE FORCEPS USED TO LOAD THE LENS. THERE WAS NO ISSUE WITH THE LENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6265488 ↗
• MalfunctionDec 20, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON INSERTED A CQ2015A COLLAMER THREE PIECE LENS, +12.5 DIOPTER, AND THE LENS TORE. THE LENS WAS CUT INTO TWO PIECES TO REMOVE FROM THE PATIENT'S EYE AND THERE WAS NO PATIENT INJURY. ANOTHER SAME MODEL AND DIOPTER LENS WAS IMPLANTED. THE REPORTER INDICATED THE CAUSE MAY HAVE BEEN DUE TO TECHNICAL ERROR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6191923 ↗

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