Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102476)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841542102476), received between May 27, 2016 and May 15, 2023 — classified as 4 injuries, 8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD INDICATED THAT THE SURGEON IMPLANTED A CC4204A; +24.0 DIOPTER INTRAOCULAR LENS INTO THE PATIENT'S EYE. THE REPORTER INDICATES THEY COULDN'T SEE CORRECTLY OUT OF THE LENS FOR THE PAST 4-5 YEARS. THE PATIENT ALSO INDICATED THE SURGEON NOTED "THAT SHE HAS SCAR TISSUE BEHIND THE LENS". LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16934646 ↗
• MalfunctionSep 19, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2019 A CC4204A +24.0 DIOPTER, INTRAOCULAR LENS WAS TORN. 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 9088372 ↗
• MalfunctionJul 16, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A INTRAOCULAR LENS, DIOPTER +24.0 WAS REQUESTED TO BE RETURNED. REPORTER STATES THE LENS HAS A TORN HAPTIC AND THERE WAS NO PATIENT CONTACT WITH THE LENS. THIS OCCURRED ON (B)(6) 2019. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Patient Involvement

  MAUDE report 8795446 ↗
• MalfunctionMar 20, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A CC4204A COLLAMER SINGLE PIECE LENS, +24.0 DIOPTER, CRUMPLED AND THERE WAS NO PATIENT CONTACT. THE REPORTER INDICATED THEY HAVE SOME NEW NURSES THAT ARE LEARNING THE SYSTEM. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 8438545 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A CC4204A, +24.0 DIOPTER, INTRAOCULAR LENS INTO THE PATIENT'S EYE ON (B)(6) 2018. WITHIN THE INITIAL SURGERY, THE SURGEON NOTED THE LENS DID NOT LOOK RIGHT AND THE LENS WAS REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S LENS. IT WAS REPORTED THAT PATIENT'S CAPSULE WAS COMPROMISED, NOT SURE IF IT WAS BECAUSE OF 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 Code Available; Vitrectomy

  MAUDE report 8256678 ↗
• MalfunctionMar 6, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A CC4204A, +24.0 DIOPTER, INTRAOCULAR LENS WAS RETURNED DAMAGED TO THE MANUFACTURER. THE REPORTER INDICATED THAT THERE WAS NO PATIENT CONTACT WITH THE LENS. ADDITIONAL INFORMATION WAS UNABLE TO BE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7318881 ↗
• MalfunctionDec 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGERY IMPLANTED A CC4204A, +24.0 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S EYE ON (B)(6) 2017. DURING LENS INSERTION, THE LENS TORE TO WHAT THE REPORTER SAID WAS DUE TO A LOADING ERROR. THE LENS WAS EXCHANGED INTRAOPERATIVELY WITH A SIMILAR LENS. IT WAS SUCCESSFUL AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7089421 ↗
• MalfunctionOct 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT, AS THE SURGEON IMPLANTED A CC4204A IMPLANTABLE COLLAMER LENS, DIOPTER +24.0 INTO THE PATIENT'S LEFT (OS) EYE, HE NOTICED THE LENS WAS TORN. THE LENS WAS IMPLANTED. THE LENS WAS EXCHANGED WITH THE STAAR BACK-UP LENS INTRAOPERATIVELY, WITH NO PATIENT EVENT OR INJURY. THE SURGEON DOES NOT KNOW DURING WHICH PART OF THE PROCESS THE LENS TORE. THIS OCCURRED ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6978077 ↗
• MalfunctionJun 28, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE CUSTOMER RETURNED THE LENS IMPLANT CARD FOR A CC4204A COLLAMER SINGLE PIECE LENS, +24.0 DIOPTER, AND REPORTED THE LENS DID NOT DEPLOY PROPERLY AND WAS EXPLANTED. 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 6675654 ↗
• InjuryMar 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CC4204A COLLAMER SINGLE PIECE LENS, +24.0 DIOPTER WAS RETURNED TO THE MANUFACTURER WITH NO DAMAGE. THE FACILITY REPORTED COMPLICATIONS ON (B)(6) 2016 AND THE DOCTOR CHANGED TO A THREE PIECE 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 Code Available

  MAUDE report 6412056 ↗
• InjuryJul 14, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE REPORTER INDICATED THE SURGEON IMPLANTED A CC4204A COLLAMER SINGLE PIECE LENS +24.00 DIOPTER, IN THE PATIENT'S LEFT EYE ON (B)(6) 2016. THE LENS WAS EXPLANTED AND A VITRECTOMY WAS PERFORMED. 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 Code Available; Vitrectomy

  MAUDE report 5796475 ↗
• InjuryMay 27, 2016Torn Material; Torn Material

  THE REPORTER STATED THE SURGEON INSERTED A CC4204A SINGLE-PIECE COLLAMER LENS, +24.0 DIOPTER, IN THE PATIENT'S EYE AND ONE END OF THE LENS WAS CUT. THE LENS WAS CUT IN HALF TO REMOVE FROM THE EYE WITHIN THE SAME SURGERY. THE BACKUP LENS WAS IMPLANTED AND ONE SUTURE WAS USED TO CLOSE THE WOUND. THE REPORTER STATED THE CAUSE OF THE EVENT WAS THE SURGEON LOADED THE LENS INCORRECTLY AND THERE WAS NO DEVICE MALFUNCTION.

  Patient problems: No Code Available

  MAUDE report 5685246 ↗

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