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

Model Number	PSCST30
Medical Device Problem Codes	Break (1069); Crack (1135); Failure to Eject (4010)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable as this is not an implantable device.  if explanted, give date: not applicable as this is not an implantable device.  (b)(4).All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that while attempting to insert lens into patient¿s operative eye, lens became stuck in cartridge and haptic of lens was bent.There was patient contact and the lens was partially inserted, removed and replaced in same surgical procedure.Incision enlargement was required during this procedure.No vitrectomy required.No further information 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 available for evaluation: yes.Returned to manufacturer on: 8/14/2020.Device returned to manufacturer: yes.Device code: 1135¿ cartridge tip damage.Device evaluation: the product was received at site and was evaluated, and the cartridge was observed with a lens stuck in cartridge.The lens was stuck and didn¿t come out of the cartridge.Also, the tip of the cartridge was damaged and the wing broken.Due to the condition in which the sample returned the reported issue haptic damaged was not verified however, stuck in cartridge and device partially delivered, wing broken and tip damaged were confirmed.However, batch ce07812 is within the scope of capa-009710, to investigate delivery issues or events with the silver cartridges (pscst).Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that 17 additional complaint was received from this production order and all products met manufacturing release criteria and had no deficiency.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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: 10382973
• Report Number: 2648035-2020-00598
• Device Sequence Number: 14343623
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)200821(10)CE07812
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2020
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: CE07812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 08/18/2020; 10/25/2020
• Initial Report FDA Received Date: 08/08/2020
• Supplement Report FDA Received Date: 09/15/2020; 10/29/2020
• 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: MODEL Z9002 LENS SN: (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005