Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102360)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841542102360), received between Mar 16, 2017 and Jun 5, 2021 — classified as 3 injuries, 6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2021Adverse 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 THAT A CC4204A, +20.0 DIOPTER, INTRAOCULAR LENS TORE DURING INSERTION. REMOVED WITH NO PATIENT COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943905 ↗
• InjuryFeb 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER STATES THAT BEFORE THE SURGEON INJECTED A CC4204A INTRAOCULAR LENS, DIOPTER +18.5, HE "LOOKED AT THE LENS IN THE INJECTOR AND NOTICED THAT SOMETHING LOOKED WRONG SO HE EJECTED THE LENS OUTSIDE THE EYE AND THE LENS WAS TORN." THERE WAS NO PATIENT CONTACT WITH THE LENS. THIS OCCURRED ON (B)(6) 2019.

  Patient problems: No Patient Involvement

  MAUDE report 9690225 ↗
• MalfunctionJan 14, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A INTRAOCULAR LENS, DIOPTER +18.5 WAS RETURNED AS OPENED AND NOT USED. HOWEVER, ONCE RECEIVED, IT WAS NOTED THAT THERE IS A TEAR ON IT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9587401 ↗
• MalfunctionNov 12, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +18.50 DIOPTER, INTRAOCULAR LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT WITH THE DEVICE AND A BACK-UP LENS WAS IMPLANTED SUCCESSFULLY. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 9313024 ↗
• MalfunctionSep 18, 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 THAT, AS THE SURGEON WAS IMPLANTING A CC4204A INTRAOCULAR LENS, DIOPTER +18.5 INTO THE PATIENT'S LEFT (OS) EYE, HE NOTICED THAT THE INCISION WAS NOT LARGE ENOUGH TO IMPLANT THE LENS. THE LENS WAS REMOVED IN ORDER TO ENLARGE THE INCISION AND AN ALTERNATE LENS WAS SUCCESSFULLY IMPLANTED. THIS OCCURRED ON (B)(6) 2018.

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

  MAUDE report 7886302 ↗
• MalfunctionJul 27, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A CC4204A, +18.5 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING THE LOADING PROCESS. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7727114 ↗
• MalfunctionDec 12, 2017Device Operates Differently Than Expected; Mechanical Jam; Device Operates Differently Than Expected; Mechanical Jam

  THE REPORTER INDICATED THAT, AS THE SURGEON WAS LOADING A CC4204A INTRAOCULAR LENS, DIOPTER +18.5, IN PREPARATION TO IMPLANT INTO THE PATIENT'S EYE, THE LENS GOT STUCK IN THE INJECTOR. REPORTEDLY, THERE WAS NO PATIENT CONTACT WITH THE LENS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7109990 ↗
• InjuryJul 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THAT THE SURGEON IMPLANTED A CC4204A COLLAMER SINGLE PIECE LENS, +18.5 DIOPTER, AND NOTICED A TEAR ON THE CAPSULE. A VITRECTOMY WAS PERFORMED AND THE SURGEON IMPLANTED A DIFFERENT LENS. NO INCISION ENLARGEMENT OR SUTURERS WERE REQUIRED. THE REPORTER STATED THAT THE CAUSE OF THE EVENT WAS NOT PRODUCT RELATED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6716039 ↗
• MalfunctionMar 16, 2017Scratched Material; Scratched Material

  A CC4204A COLLAMER SINGLE PIECE LENS, +18.5 DIOPTER WAS RETURNED TO THE MANUFACTURER DAMAGED. 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 6412059 ↗

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