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

Model Number PSCST30

Device Problems Break (1069); Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2022

Event Type  malfunction  

Manufacturer Narrative

Unknown, as information was asked but not provided.Date implanted: not applicable, as the cartridge is not an implantable device.Date explanted: not applicable, as the cartridge is not an implantable device.It was indicated that both the pscst cartridge and the z9002 iol are not being returned for evaluation as they were both discarded therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt was made to obtain missing information.However; the account did not provide some information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported the unloader did something to damage the intraocular lens (iol).Through follow-up, additional information was received clarifying the tip of the pscst unfolder (cartridge) was observed under microscope by surgeon to be damaged and have a jagged edge.The z9002 lens was already in the inserter, so it could not be reused with a new inserter.The damaged tip was not visible to the naked eye, only under the microscope at the time of insertion.Cartridge tip had patient contact.It was confirmed the pscst cartridge was inspected inspected under microscope prior to use.A new lens with the same model and diopter size and inserter were used to complete the procedure.There was no unplanned incision enlargement, no serious patient injury, no unplanned suture(s), and no unplanned vitrectomy.Patient outcome post-procedure was reported as positive.The iol and the cartridge are not available for return as they were both discarded.No further information is available.

• Brand Name: UNFOLDER SILVER
• Type of Device: 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: 14384338
• MDR Text Key: 300076300
• Report Number: 3012236936-2022-01239
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)220924(10)CJ30828
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: Z9002 IOL SN: (B)(4)
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White