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

Model Number	PSCST30
Medical Device Problem Codes	Break (1069); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the intraocular lens (iol) was partially inserted into the patient's ocular sinister (left eye), but the back haptic was stuck in the silver pscst30 cartridge.When the doctor tried to correct this the haptic bent.The lens was removed and another lens, same model and diopter was implanted.There was no patient injury, and no medical intervention or surgical intervention was required.Patient outcome post-procedure was reported as fine.A 10-second delay was reported, and possible use error.No further information is available.
Additional Manufacturer Narrative
The device was not returned for analysis therefore, a visual analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.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.
Additional Manufacturer Narrative
Correction: upon further review, it was noted that in the initial mdr section h-6 device code haptic damage was inadvertently not captured, however the haptic damage information was captured in section b-5 event description.Therefore, this supplemental filing is to correct the medical device problem code 1069 that was originally not captured.The following section has been updated accordingly: section h6:medical device problem code: 1069 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13116085
• Report Number: 3012236936-2021-00380
• Device Sequence Number: 4485724
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)220413(10)CJ18802
• 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 Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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 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: 12/02/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 02/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Z9002 22.5D IOL SN: (B)(6).
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Race: Black Or African American