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

Model Number	PSCST30
Medical Device Problem Codes	Crack (1135); Inaccurate Delivery (2339); Mechanical Jam (2983); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight, ethnicity: unknown/asked but unavailable.Lot number: unknown, as information was not provided.Expiration date: unknown as product lot number was not provided.Udi number: a complete udi number is unknown as product 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.Device manufacture date: unknown, as the lot number was not provided.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.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 confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
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.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: nov 30, 2021.Device evaluation: the complaint lens was received inside the original lens case.No cartridge was received as part of the return, therefore, no product evaluation could be performed on the cartridge.Visual inspection of the suspect lens under magnification revealed viscoelastic residue on the optic body and haptics.The lens was cleaned, and a torn iol and a damage haptic (bent) was observed.The complaint issues of "stuck in cartridge", "delivery issue", and "cartridge crack" count not be confirmed.The complaint issue of iol torn was confirmed; however, based on the fact that the lens was handled during insertion this issue can be attributed to handling and cannot be confirmed to be related to manufacturing.Therefore no product deficiency could be identified.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: 12682419
• Report Number: 2020664-2021-07855
• Device Sequence Number: 17184971
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(10)UNKNOWN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

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 Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• 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: 09/28/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Z9002 22.0 SN: (B)(4)
• Patient Sex: Female