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	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight and ethnicity: unknown, information not provided.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.  all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
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.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed since the product was not returned for evaluation.However, a photo was provided and evaluation of the photo was performed.The pscst30 cartridge used for the implantation of the iol was observed damaged.The cartridge tip was observed bent and deformed.The complaint issue reported was verified.However, based on the evidence observed and since the cartridge is not available for a thoroughly evaluation, the complaint issue reported could not be determined if is related to manufacturing and/or surgical process.Product deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that one additional complaint was received from this production order, however, condition reported for additional complaint folder is not related to the complaint issue reported.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12652387
• Report Number: 2020664-2021-07734
• Device Sequence Number: 4489587
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)220413(10)CJ18802
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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: 04/13/2022
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: CJ18802
• Was Device Available for Evaluation?: No
• 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: 09/22/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LENS MODEL NUMBER: Z9002; LENS MODEL NUMBER: Z9002
• Patient Sex: Female