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); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: weight and ethnicity: unknown, information not provided.If implanted, give date: not applicable, as the cartridge is not an implantable device.If explanted, give date: not applicable, as the cartridge is not an implantable device.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.Should additional information be received regarding this event the case will be reopened and processed accordingly.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
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.
Additional Manufacturer Narrative
Additional information: section h-2: device evaluation.Section h-3: device evaluated by manufacturer: yes device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed that four (04) additional complaint folders for this production order (po) number.Two (02) of the four (04) complaint folders are related to the complaint issue reported, but pending investigation results.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that in the initial mdr section h6, device codes device partially delivered, haptic damage, and iol torn were inadvertently not captured.Therefore, this supplemental filing is to correct the medical device problem codes there were was not originally captured.The following sections have been updated accordingly: section h6:medical device problem code: 1069 haptic damage, 2920 device partially delivered, 4008 iol torn.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: 11750446
• Report Number: 2648035-2021-07637
• Device Sequence Number: 3856348
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)210923(10)CH14579
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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 faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2021

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: 09/23/2021
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: CH14579
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 05/03/2021; 08/09/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 05/26/2021; 08/09/2021
• 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 SERIAL NUMBER (B)(6).
• Patient Age: 86 YR