Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CQ2015A (UDI 00841542102049)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542102049), received between Nov 2, 2017 and Dec 30, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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.

• MalfunctionDec 30, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CQ2015A INTRAOCULAR LENS, DIOPTER +23.0 WAS RETURNED TO THE MANUFACTURER WITH THE WORDS "DID NOT USE" RECORDED ON THE BOX. HOWEVER, THE LENS WAS RETURNED DAMAGED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11098615 ↗
• InjurySep 3, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CQ2015A, +23.0 DIOPTER, INTRAOCULAR LENS WAS DAMAGED DURING INSERTION INTO THE PATIENT'S RIGHT EYE ON (B)(6) 2019. NO PATIENT INJURY WAS REPORTED. THE BACKUP LENS WAS IMPLANTED AND PROBLEM RESOLVED, PATIENT "DOING/SEEING WELL." PER REPORTER, ANTERIOR VITRECTOMY PERFORMED AT THE SAME TIME. POSTERIOR CAPSULAR RENT AND USE OF CAPSULAR TENSION RING WERE OBSERVED DURING SURGERY. CAUSE OF THE EVENT IS REPORTED AS PATIENT RELATED FACTOR.

  Patient problems: Capsular Bag Tear; No Known Impact Or Consequence To Patient; Vitrectomy

  MAUDE report 8957647 ↗
• MalfunctionSep 25, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AS THE CQ2015A INTRAOCULAR LENS, DIOPTER +23.0 WAS BEING INJECTED INTO THE PATIENT'S LEFT (OS) EYE, THE HAPTIC BROKE INSIDE OF THE LENS INSERTER. REPORTEDLY, THIS WAS DUE TO THE LENS BEING "MISLOADED BY THE TECH." THE LENS WAS EXPLANTED INTRAOPERATIVELY. THIS OCCURRED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7906884 ↗
• MalfunctionNov 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE CQ2015A, +23.0 DIOPTER, INTRAOCULAR LENS GOT STUCK IN THE CARTRIDGE. ATTEMPTS AT OBTAINING ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6997274 ↗

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