Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102346)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00841542102346), received between Jan 13, 2017 and Mar 10, 2020 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A CC4204A COLLAMER SINGLE PIECE LENS, +17.5, IN THE PATIENTS EYE. THE LENS WAS EXPLANTED DUE TO BEING TOO LARGE AND WAS REPLACED WITH ANOTHER SAME TYPE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 9814209 ↗
• MalfunctionNov 5, 2019Material Integrity Problem; Material Integrity Problem

  A CC4204A COLLAMER SINGLE PIECE LENS, +17.5 DIOPTER, WAS FOUND TO BE DAMAGED IN THE LENS VIAL. THE VIAL WAS OPENED BUT THE LENS WAS NOT REMOVED OR USED AND THERE WAS NO PATIENT CONTACT. THERE WAS A PROBLEM WITH THE PATIENTS CAPSULE SO THE SURGEON DECIDED NOT TO USE THE LENS. THE REPORTER INDICATED THEY WERE NOT AWARE THE LENS WAS DAMAGED AND WERE UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 9282376 ↗
• MalfunctionJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A CC4204A, +17.5 DIOPTER, INTRAOCULAR LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7678313 ↗
• MalfunctionApr 6, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A CC4204A COLLAMER SINGLE PIECE LENS, +17.5 DIOPTER, BUT THE LENS TORE. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7405058 ↗
• InjuryFeb 24, 2018Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information

  THE REPORTER INDICATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +17.5 DIOPTER, IN THE PATIENT'S RIGHT (OD) EYE. UPON INSERTION, THE POSTERIOR CAPSULE WAS TORN. THE LENS WAS CUT IN HALF TO REMOVE FROM THE EYE WITHIN THE SAME SURGERY, WITH NO PATIENT INJURY. A VITRECTOMY WAS PERFORMED AND AN ANTERIOR CHAMBER LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN. THE LENS WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 7294654 ↗
• MalfunctionJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A (B)(4) COLLAMER SINGLE PIECE LENS, +17.5 DIOPTER, WAS WASTED AND THE SURGEON ENDED UP IMPLANTING A NON-STAAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED , A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7169802 ↗
• MalfunctionJun 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THAT A CC4204A COLLAMER SINGLE PIECE LENS, +17.5 DIOPTER WAS USED AND WAS BEING RETURNED DUE TO A UNPLANNED ANTERIOR VITRECTOMY, SUTURES WERE REQUIRED. NO IOL WAS IMPLANTED AFTER ANTERIOR VITRECTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Vitrectomy

  MAUDE report 6675859 ↗
• InjuryJun 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A MICL12.6, -9.0 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 6624647 ↗
• MalfunctionMar 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON INSERTED A CC4204A COLLAMER SINGLE PIECE LENS, +17.5 DIOPTER, AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6401558 ↗
• MalfunctionJan 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON ATTEMPTED TO INSERT A CC4204A COLLAMER SINGLE PIECE LENS, +17.5 DIOPTER, AND NOTED, UNDER THE MICROSCOPE, THE LENS WAS DAMAGED. THE LENS TOUCHED THE PATIENT'S EYE AND WAS NOT INSERTED. THERE WAS NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6251940 ↗

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-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-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-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