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

Model Number PSCST30

Device Problem Failure to Eject (4010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2020

Event Type  malfunction  

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 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.

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).

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
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9887154
• MDR Text Key: 185224768
• Report Number: 2648035-2020-00292
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: Z9002 LENS SN:(B)(4).; Z9002 LENS SN:(B)(4)