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

Model Number PSCST30

Device Problem Failure to Eject (4010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number: unknown, information not provided.Expiration date: unknown, as the lot number was not provided.Udi number: a complete udi number is 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.Device manufacture date: unknown, as the lot number was not provided.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a pscst30 cartridge was used when inserting a model z9002 intraocular lens (iol).The iol was inserted into the cartridge but the customer thinks that the lens was too thick.When the attempt was made to get the lens into the patient¿s left eye, it would not unfold in the eye.Although the customer is not sure what part of the lens had patient contact as the lens also got stuck in cartridge, the customer was certain that the inserter went into the eye.They used the same model iol and diopter, attempted the procedure twice, and was finally successful on the third try.The 2nd reported attempt is being reported in a separate submission.No other information was provided.

Manufacturer Narrative

Device evaluation: the cartridge associated to the complaint has not been received at the manufacturing/investigation site; therefore, an evaluation of the product associated to the complaint is not possible, the reported issue was not verified.If the product is received after initial closure, the complaint folder will be re-opened to complete the investigation as stated (b)(4).Manufacturing record review: the product identifiers are not available therefore a manufacturing record review is not possible.Since the product identifiers are unknown a search of complaints related to the production order is not possible.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.

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 nr-0148919 and capa-010215.

Manufacturer Narrative

Corrected data: upon further review it was noticed that aware date for cie for suspect cartridge provided in the 1st follow-up report was incorrect.Correct aware date should be nov.27, 2019 instead of nov.20, 2019.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: 9339402
• MDR Text Key: 178747828
• Report Number: 2648035-2019-01215
• 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,Followup
• Report Date: 01/01/2005,11/06/2020

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
• 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
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 11/20/2019; 12/16/2019; 10/25/2020
• Supplement Dates FDA Received: 12/16/2019; 01/14/2020; 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: Z9002 LENS SN: (B)(4)
• Patient Age: 69 YR