Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens CC4204A (UDI 00841542102452)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841542102452), received between Feb 28, 2017 and Jun 25, 2019 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THE REPORTER INDICATED THAT A CC4204A, +23.00 DIOPTER, INTRAOCULAR LENS WAS REMOVED WITH NO PATIENT INJURY AND REPLACED WITH ANOTHER STAAR LENS DUE TO POSTERIOR VAULT. THE REPORTER STATED " EQUATOR TO EQUATOR DIAMETER IS TO SMALL, CAUSED LENS TO POSTERIOR VAULT".

  Patient problems: No Code Available

  MAUDE report 8731917 ↗
• MalfunctionMay 9, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CC4204A INTRAOCULAR LENS, DIOPTER +23.0 WAS RETURNED DAMAGED, THOUGH "OPENED NOT USED" WAS RECORDED ON THE BOX. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8595417 ↗
• MalfunctionApr 4, 2018Positioning Failure; Positioning Failure

  THE REPORTER INDICATED THAT THE SURGEON ATTEMPTED TO IMPLANT A CC4204A, +23.0 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S EYE ON (B)(6) 2018. IT WAS REPORTED THAT THE PLUNGER WOULD NOT WORK AS IT WOULD NOT ADVANCE. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. ANOTHER STAAR LENS WAS IMPLANTED. NO OTHER ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7398186 ↗
• MalfunctionDec 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A CC4204A, +23.0 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S EYE ON (B)(6) 2017. IT WAS NOTICED THAT THE LENS HAS LATHE MARKS ON IT. THE LENS REMAINS IMPLANTED IN THE EYE. THERE ARE NO PATIENT COMPLICATIONS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7131229 ↗
• MalfunctionOct 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON ATTEMPTED TO IMPLANT A CC4204A, 23.0 DIOPTER, INTRAOCULAR LENS IN THE PATIENT'S EYE ON (B)(6) 2017. THE LENS GOT STUCK IN THE CARTRIDGE, SO A BACK UP LENS WAS USED. THERE WAS NO PATIENT CONTACT WITH THE FIRST LENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6952433 ↗
• MalfunctionMar 14, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE REPORTER STATED THE SURGEON ATTEMPTED TO INSERT A CC4204A COLLAMER SINGLE PIECE LENS, +23.0 DIOPTER, BUT NOTED THE LENS WAS TORN. THERE WAS PATIENT CONTACT BUT NO INJURY. THE REPORTER STATED THAT LENS MOST LIKELY TORE DURING THE LOADING PROCESS AND WAS DUE TO A LOADING ERROR. THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6404846 ↗
• MalfunctionFeb 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT THE SURGEON IMPLANTED A CC4204A, +23.0 DIOPTER, IMPLANTABLE COLLAMER LENS BUT DID NOT LIKE THE WAY THE LENS LOOKED. THE SURGEON REMOVED THE LENS AND REPLACED IT WITH A CQ2015A THREE PIECE COLLAMER LENS DURING THE SAME SURGERY. THERE WAS NO CAPSULE TEAR AND NO INJURY TO THE PATIENT. THERE WAS NO ENLARGED INCISION OR SUTURES NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6364685 ↗

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