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

Model Number	PSCST30
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number: unknown, as information was not provided.Expiration date: unknown as product lot number was not provided.Udi #: udi # is unknown as product lot number was not provided.Device manufacture date: unknown, as the lot number was not provided.If implanted, give date: n/a (not applicable).The cartridge is not an implantable device.If explanted, give date: n/a (not applicable).The cartridge is not an implantable device; therefore, not explanted.The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and historical complaint review cannot be conducted as the lot number of the device was not provided.If there is any further relevant information received a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
Customer reported that the injector (cartridge) split and then bent the lens haptic.There was patient contact.No additional information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation? yes, returned to manufacturer on: 09/30/2021, device evaluated by manufacturer¿ yes.Device evaluation: no cartridge was received as part of the product return.Visual inspection of the lens under magnification revealed that the lens had viscoelastic residue on the optic body and haptics.The lens was cleaned, and lens damage and a damaged haptic (bent) were observed.The complaint issue was confirmed; however, based on the fact that the lens was handled during an insertion attempt it may be attributed to handling and cannot be confirmed to be related to manufacturing.Therefore, no product deficiency could be identified.Manufacturing record review: the manufacturing record could not be reviewed since the lot number was not provided.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
Additional info: further information was provided and reported the lens and cartridge contacted the patient's left eye.The lens was not partially delivered.There was no vitrectomy, incision enlargement, or sutures required.The procedure was completed successfully with another johnson & johnson z9002 lens (same model and 21.5 diopter).Patient's outcome was good.The patient's gender was provided as a male.The cartridge lot number is unknown.No additional information provided.The following section has been updated accordingly: section a3: sex/gender: male.Device evaluation: product testing could not be performed since at the time of this investigation, the product has not been received for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record review: the manufacturing record could not be reviewed since the lot number was not provided.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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
• MDR Report Key: 12322029
• Report Number: 2648035-2021-08314
• Device Sequence Number: 19539551
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(10)UNKNOWN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2021

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 Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/25/2021; 10/24/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/22/2021; 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Z9002 LENS SN: (B)(4)