Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542101943)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542101943), received between Jan 17, 2018 and Jun 14, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON NOTICED TORN/BROKEN HAPTIC ON A CQ2015A, +18.0 DIOPTER, INTRAOCULAR LENS DURING LOADING. THERE NO PATIENT CONTACT. BACK UP LENS WAS IMPLANTED DURING INITIAL SURGERY, PROBLEM RESOLVED. THE REPORTER INDICATED THAT THE SURGEON DID NOT SAY WHAT HE BELIEVED TO BE THE CAUSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8699726 ↗
• InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON INSERTED A CQ2015A COLLAMER THREE PIECE LENS, +18.0 DIOPTER, AND THE LENS WAS DAMAGED. THE LENS WAS REMOVED WITH NO PATIENT INJURY. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/DIOPTER LENS. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS DUE TO TECHNICAL ERROR.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7899774 ↗
• MalfunctionMar 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A CQ2015A, +18.0 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. DURING INSERTION, THE SURGEON FELT THE INJECTOR GOT HARDER TO PUSH WHEN INJECTING THE LENS. THE TRAILING HAPTIC AND A BIT OF THE OPTIC GOT CAUGHT BY THE PLUNGER. THE LENS HAD TO BE CUT OUT. A BACK-UP SIMILAR LENS WAS INTRAOPERATIVELY EXCHANGED WITH IT AND IT WAS SUCCESSFULLY IMPLANTED. THERE WAS NO PATIENT INJURY. IT WAS ALSO REPORTED THAT THE ANIKAVISC VISCOELASTIC WAS USED AND THE LENS WAS IN THE INJECTOR FOR LESS THAT A MINUTE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7378743 ↗
• MalfunctionJan 17, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT AS THE SURGEON WAS ATTEMPTING TO LOAD THE (B)(4) INTRAOCULAR LENS, DIOPTER +18.0, THE LENS "TORE WHILE PUTTING IT IN THE CARTRIDGE." THE HAPTIC TORE WHILE INSERTING INTO CARTRIDGE, THERE WAS NO PATIENT CONTACT WITH THIS LENS. REPORTER STATES THAT NOTHING UNUSUAL OCCURRED DURING THE LOADING PROCESS. DATE OF OCCURRENCE IS (B)(6) 2017.

  Patient problems: No Patient Involvement

  MAUDE report 7202555 ↗

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