MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SILVER; SURGICAL ADJUNCTS

Model Number	PSCST30
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Expiration date: unknown, as the lot number was not provided.Lot number: unknown, information not provided.Udi number: unknown, as the lot number was not provided.Catalog number: 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.An attempt has been made to obtain missing information; however, no definitive response has been received.The reported lens damage is being submitted in a vmsr filing.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a z9002 intraocular lens was loaded into the silver shooter when the doctor tried to insert it in the patient¿s eye.The lens did not disengage from the cartridge.The doctor handed the iol back to the scrub tech and asked that she reloads the lens.But when the scrub tech was attempting to reload the iol, she noticed markings on the lens in the peripheral area.It was learned that there was indeed patient contact with the lens.The lens was partially delivered, then the lens got stuck in cartridge.No other information was provided.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa (b)(4).
Additional Manufacturer Narrative
Device evaluation: the returned sample was received at site on 03/12/2020 including: packaging component (folding carton).However, the suspect cartridge was not received.The complaint issue could not be verified.However, capa-009710 was issued since there is an increase in delivery issues related to using cartridge model pscst30.Manufacturing record review: the manufacturing record cannot be reviewed since the lot number is unknown.A complaint history could not be performed since there is no lot number or production order number available.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: SILVER
• Common Device Name: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9887154
• Report Number: 2648035-2020-00292
• Device Sequence Number: 3017501
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(10)UNKNOWN
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K961242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2020
• Report Date (Section F): 01/01/2005

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?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 03/31/2020; 10/25/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/22/2020; 10/30/2020
• 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).; Z9002 LENS SN:(B)(4)
• Date Report Sent to FDA: 01/01/2005