MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER SILVER; LENS, GUIDE, INTRAOCULAR

Model Number	PSCST30
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Unknown/ asked but not available.Asku if implanted, give date: not applicable as this is not an implantable device.  if explanted, give date: not applicable as this is not an implantable device.  device evaluation: visual inspection under magnification revealed that the complaint cartridge was received with the cartridge tip and the cartridge cracked, in a way consistent with a cartridge that had been used.Further inspection of the cartridge revealed no further issues.The iol was revealed to have a bent haptic.The complaint issue of dc-cartridge crack was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed three complaints received from this production order.Although these complaint issues reported are related, the issue could not be confirmed as related to manufacturing; therefore, no escalations are required.Conclusion: as a result of the investigation there is no indication of a product deficiency or product malfunction.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNFOLDER SILVER
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15670109
• Report Number: 3012236936-2022-02559
• Device Sequence Number: 6463039
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)220924(10)CJ30828
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K961242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: CJ30828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female