UNFOLDER SILVER PSCSTRecalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 05050474530034), received between Oct 27, 2016 and Oct 25, 2022 — classified as 4 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Crack” (22 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2022Crack; Crack

  IT WAS REPORTED THAT THE CARTRIDGE SPLIT DURING INSERTION INTO THE EYE. THERE WAS PATIENT CONTACT WITH THE PATIENT'S RIGHT EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670109 ↗
• MalfunctionMay 12, 2022Break; Crack; Break; Crack

  IT WAS REPORTED THE UNLOADER DID SOMETHING TO DAMAGE THE INTRAOCULAR LENS (IOL). THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE TIP OF THE PSCST UNFOLDER (CARTRIDGE) WAS OBSERVED UNDER MICROSCOPE BY SURGEON TO BE DAMAGED AND HAVE A JAGGED EDGE. THE Z9002 LENS WAS ALREADY IN THE INSERTER, SO IT COULD NOT BE REUSED WITH A NEW INSERTER. THE DAMAGED TIP WAS NOT VISIBLE TO THE NAKED EYE, ONLY UNDER THE MICROSCOPE AT THE TIME OF INSERTION. CARTRIDGE TIP HAD PATIENT CONTACT. IT WAS CONFIRMED THE PSCST CARTRIDGE WAS INSPECTED INSPECTED UNDER MICROSCOPE PRIOR TO USE. A NEW LENS WITH THE SAME MODEL AND DIOPTER SIZE AND INSERTER WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS POSITIVE. THE IOL AND THE CARTRIDGE ARE NOT AVAILABLE FOR RETURN AS THEY WERE BOTH DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14384338 ↗
• MalfunctionApr 29, 2022Crack; Use of Device Problem; Crack; Use of Device Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD LOADING ISSUE AND THE CARTRIDGE BROKE. THERE WAS CONTACT WITH PATIENT'S RIGHT EYE AND THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER. THE EVENT WAS OBSERVED WHILE INSERTING INTO THE EYE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14257263 ↗
• MalfunctionDec 30, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT'S OCULAR SINISTER (LEFT EYE), BUT THE BACK HAPTIC WAS STUCK IN THE SILVER PSCST30 CARTRIDGE. WHEN THE DOCTOR TRIED TO CORRECT THIS THE HAPTIC BENT. THE LENS WAS REMOVED AND ANOTHER LENS, SAME MODEL AND DIOPTER WAS IMPLANTED. THERE WAS NO PATIENT INJURY, AND NO MEDICAL INTERVENTION OR SURGICAL INTERVENTION WAS REQUIRED. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS FINE. A 10-SECOND DELAY WAS REPORTED, AND POSSIBLE USE ERROR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13116085 ↗
• MalfunctionNov 12, 2021Break; Mechanical Problem; Use of Device Problem; Break; Mechanical Problem; Use of Device Problem

  QUALITY ISSUES WERE REPORTED INVOLVING Z9002 INTRAOCULAR LENSES (IOLS) AND SILVER PSCST30 CARTRIDGES, THE LENSES ARE NOT LOADING PROPERLY, BEING OVERWRITTEN, AND HAPTICS BREAKING. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR CARTRIDGE EVENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR THE LENS EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805620 ↗
• MalfunctionOct 22, 2021Crack; Inaccurate Delivery; Mechanical Jam; Material Split, Cut or Torn; Crack; Inaccurate Delivery; Mechanical Jam; Material Split, Cut or Torn

  IT WAS REPORTED WHILE INSERTING THE INTRAOCULAR LENS (IOL) IN THE LEFT EYE, IT GOT 1/3 OF THE WAY WHEN THE FRONT HAPTIC AND IOL GOT STUCK IN THE CARTRIDGE. THE SURGEON BACKED THE IOL OFF AND THE LENS TORE. AFTER THE SURGEON LOOKED AT THE CARTRIDGE, IT WAS OBSERVED CRACKED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING FINE POST-OPERATIVELY. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE SURGEON WAS ATTRIBUTING THE EVENT TO THE CARTRIDGE CRACKING. THE TIP OF THE CARTRIDGE WAS NOT DAMAGED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682419 ↗
• MalfunctionOct 18, 2021Crack; Crack

  IT WAS REPORTED THAT THE SURGEON OBSERVED A MOLDED TYPE DEFECT ON THE CARTRIDGE DURING THE IMPLANTATION OF INTRAOCULAR LENS (IOL) INTO PATIENT'S LEFT EYE. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE DEFECT WAS THAT THE CARTRIDGE APPEARED DEFORMED OR MELTED AT THE TIP. THE CARTRIDGE LOOKED THIS WAY IMMEDIATELY UPON OPENING THE ORIGINAL PACKAGE. HOWEVER, THE SURGEON WAS ABLE TO SUCCESSFULLY IMPLANT THE LENS INTO THE EYE AND HAD NO ADVERSE ISSUES DURING THE SURGERY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12652387 ↗
• MalfunctionOct 18, 2021Break; Crack; Mechanical Jam; Break; Crack; Mechanical Jam

  IT WAS REPORTED THAT THE CARTRIDGE HAD A TEAR AND THE INTRAOCULAR LENS (IOL) SPLIT. THE LENS ADVANCED SO FAR, BUT DID NOT ADVANCE FURTHERMORE. THERE WAS PATIENT CONTACT ONLY WITH THE CARTRIDGE. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12649521 ↗
• MalfunctionSep 24, 2021Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE PLUNGER OF THE INJECTOR RODE OVER THE INTRAOCULAR LENS (IOL) CAUSING THE HAPTIC TO TANGLE IN THE CARTRIDGE. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12524327 ↗
• MalfunctionAug 18, 2021Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CARTRIDGE CRACKED WHILE INSERTING THE INTRAOCULAR LENS (IOL) AND THIS RIPPED THE LENS. IT WAS THE PART THAT IS BETWEEN THE BODY OF THE CARTRIDGE THAT THE LENS IS LOADED INTO AND THE OPENING IN THE TIP THAT THE LENS TRAVELS THROUGH WHICH CRACKED. THE LENS WAS FULLY INSERTED INTO PATIENT'S LEFT EYE BUT WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT WAS DOING FINE POST-OPERATIVE (OP). NO MEDICAL OR SURGICAL INTERVENTIONS ARE PLANNED FOR FUTURE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334912 ↗
• MalfunctionAug 17, 2021Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CARTRIDGE CRACKED WHILE INSERTING THE INTRAOCULAR LENS (IOL) AND THIS RIPPED THE LENS. IT WAS THE CARTRIDGE PART THAT IS BETWEEN THE BODY OF THE CARTRIDGE THAT THE LENS IS LOADED INTO AND THE OPENING IN THE TIP THAT THE LENS TRAVELS THROUGH WHICH CRACKED. THE LENS WAS FULLY INSERTED INTO PATIENT'S OPERATIVE EYE, BUT WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO INJURY TO THE PATIENT AND NO MEDICAL/ SURGICAL INTERVENTIONS WERE REQUIRED. PATIENT WAS DOING FINE POST-OP. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334651 ↗
• MalfunctionAug 13, 2021Break; Crack; Break; Crack

  CUSTOMER REPORTED THAT THE INJECTOR (CARTRIDGE) SPLIT AND THEN BENT THE LENS HAPTIC. THERE WAS PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322029 ↗
• MalfunctionAug 9, 2021Crack; Use of Device Problem; Inaccurate Delivery; Crack; Use of Device Problem; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) DID NOT LOAD CORRECTLY AND THE CARTRIDGE HAD A DEFECT IN IT. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE TIP OF THE CARTRIDGE HAD A FORK IN IT. THE CARTRIDGE HAD A SPLIT NEAR THE TIP WHICH WAS NOT SEEN UNTIL IT WAS SEEN IN THE MICROSCOPE. DUE TO THIS, THE LENS WRAPPED AROUND THE PLUNGER INSTEAD OF CURLING UP WHEN THE PLUNGER WAS APPLIED TO INSERT THE LENS INTO THE PATIENT'S OPERATIVE EYE. THE TIP OF THE LENS WAS INSERTED INTO THE EYE, HOWEVER, THE LENS INSERTER WAS PULLED OUT BEFORE COMPLETELY PUSHING THE LENS INTO THE EYE AS THE PROBLEM WAS NOTICED THEN. NO ADDITIONAL INTERVENTION WAS REQUIRED AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT LENS AND CARTRIDGE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298536 ↗
• MalfunctionApr 30, 2021Break; Crack; Difficult to Advance; Material Split, Cut or Torn; Break; Crack; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THEY WERE TRYING TO INSERT THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S RIGHT EYE, THE UNLOADER (CARTRIDGE) SPLIT AT THE TIP AND RIPPED THE LENS AND HAPTICS. IT WAS STATED THAT THE PATIENT WAS DOING FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11751154 ↗
• MalfunctionApr 29, 2021Break; Crack; Difficult to Advance; Material Split, Cut or Torn; Break; Crack; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED WHEN INSERTING THE INTRAOCULAR LENS (IOL), THEY TRIED PUSHING THE IOL, AND THE PSCST30 CARTRIDGE SPLIT AT THE TIP AND RIPPED THE LENS AND HAPTICS. THE LENS WAS NOT STUCK IN THE CARTRIDGE AND THERE WAS NO PATIENT INJURY. ANOTHER JOHNSON AND JOHNSON LENS WITH THE SAME MODEL AND DIOPTER SIZE WAS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). PATIENT POST-OP STATUS WAS REPORTED AS DOING FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11750446 ↗
• MalfunctionApr 29, 2021Break; Crack; Difficult to Advance; Material Split, Cut or Torn; Break; Crack; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED WHEN INSERTING THE INTRAOCULAR LENS (IOL), THEY TRIED PUSHING THE IOL, AND THE PSCST30 CARTRIDGE SPLIT AT THE TIP AND RIPPED THE LENS AND HAPTICS. THE LENS WAS NOT STUCK IN THE CARTRIDGE AND THERE WAS NO PATIENT INJURY. ANOTHER JOHNSON AND JOHNSON LENS WITH THE SAME MODEL AND DIOPTER SIZE WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). PATIENT POST-OP STATUS WAS REPORTED AS DOING FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11750434 ↗
• MalfunctionJan 31, 2021Break; Break

  THIS REPORT SUMMARIZES (NOE) 1 (/NOE) MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11256466 ↗
• MalfunctionJan 29, 2021Crack; Crack

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND REMOVED AND REPLACED FROM THE PATIENT'S RIGHT EYE IN THE SAME PROCEDURE AS THE INSERTER TIP WAS BENT AND WAS UNABLE TO INSERT THE LENS CORRECTLY. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL) WAS IMPLANTED AS A REPLACEMENT. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11249151 ↗
• MalfunctionOct 26, 2020Crack; Device Damaged by Another Device; Failure to Eject; Crack; Device Damaged by Another Device; Failure to Eject

  IT WAS REPORTED THAT SURGEON COULD NOT GET THE LENS TO PUSH THROUGH THE INSERTER. THERE WAS PATIENT CONTACT. THERE WAS NO MEDICAL INTERVENTIONS TAKEN. THE SURGERY CONTINUED WITH NO PROBLEMS USING ANOTHER LENS OF THE SAME MODEL AND DIOPTER POWER WAS USED TO COMPLETE THE PROCEDURE. THE EVENT WAS OBSERVED WHEN INSERTING LENS INTO THE EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10738601 ↗
• InjuryAug 8, 2020Break; Crack; Failure to Eject; Break; Crack; Failure to Eject

  IT WAS REPORTED THAT WHILE ATTEMPTING TO INSERT LENS INTO PATIENT¿S OPERATIVE EYE, LENS BECAME STUCK IN CARTRIDGE AND HAPTIC OF LENS WAS BENT. THERE WAS PATIENT CONTACT AND THE LENS WAS PARTIALLY INSERTED, REMOVED AND REPLACED IN SAME SURGICAL PROCEDURE. INCISION ENLARGEMENT WAS REQUIRED DURING THIS PROCEDURE. NO VITRECTOMY REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10382973 ↗
• MalfunctionAug 5, 2020Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  IT WAS REPORTED THAT LENS RIPPED WHILE INSERTING. REPORTEDLY, HALF OF THE LENS FLEW OFF THE FIELD AND CUSTOMER BELIEVES THE REASON FOR LENS BEING RIPPED COULD HAVE BEEN DUE TO THE INJECTOR WHICH HAS BEEN REPLACED. THE LENS WAS PARTIALLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF THE SAME MODEL AND DIOPTER. PATIENT IS DOING FINE. THIS REPORT WILL CAPTURE THE REPORTED PARTIAL DELIVERY RELATED TO THE CARTRIDGE. A SEPARATE REPORT WILL BE SUBMITTED AS PART OF VOLUNTARY MALFUNCTION SUMMARY REPORT FOR THE LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10371195 ↗
• MalfunctionJul 22, 2020Crack; Crack

  THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO CARTRIDGE TIP CRACKED OR DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310855 ↗
• MalfunctionMar 26, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS WAS LOADED INTO THE SILVER SHOOTER WHEN THE DOCTOR TRIED TO INSERT IT IN THE PATIENT¿S EYE. THE LENS DID NOT DISENGAGE FROM THE CARTRIDGE. THE DOCTOR HANDED THE IOL BACK TO THE SCRUB TECH AND ASKED THAT SHE RELOADS THE LENS. BUT WHEN THE SCRUB TECH WAS ATTEMPTING TO RELOAD THE IOL, SHE NOTICED MARKINGS ON THE LENS IN THE PERIPHERAL AREA. IT WAS LEARNED THAT THERE WAS INDEED PATIENT CONTACT WITH THE LENS. THE LENS WAS PARTIALLY DELIVERED, THEN THE LENS GOT STUCK IN CARTRIDGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9887154 ↗
• MalfunctionMar 17, 2020Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT WHILE INSERTING INTO THE EYE, THE LENS WAS STICKING IN THE CARTRIDGE. THE LENS WAS PARTIALLY INSERTED INTO THE EYE WHEN LENS WAS NOTED TORN. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9845970 ↗
• MalfunctionMar 9, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT A MODEL Z9002 IOL 22.0 DIOPTER INTRAOCULAR LENS (IOL) SUDDENLY CAME OUT UPSIDE DOWN INTO THE PATIENT'S LEFT EYE. THE IOL WAS REMOVED. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT. ANOTHER CARTRIDGE WAS USED AND THE SAME PROBLEM OCCURRED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE EVENT FOR TWO OF TWO CARTRIDGES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9809268 ↗