MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. 1 SERIES ULTRA CARTRIDGE; SURGICAL ADJUNCTS

Model Number 1VIPR30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, not provided, best estimate is (b)(6) 2019.If implanted, if explanted, give date: not applicable, as the product is not implantable.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

A surgeon reported receiving information via social media regarding intraocular inflammation (fibrin and endoph (endophthalmitis) like related to a batch of 1vipr30 cartridges.Attempts have been made for additional information to clarify the event, however no further information is available.

Manufacturer Narrative

Device evaluation: the product testing could not be performed because the product was not returned.The complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was reviewed, and no discrepancy was found during the mrr (manufacturing record review).A review of manufacturing production order (po) was conducted and no non- conformance reports (nc) were found associated to the po.The units were manufactured and released according to the product specifications.The sterilization records were also reviewed, and no issues was reported.The units were processed according to sterilization requirements and met the product specifications.A search in complaint system revealed no additional investigation request (ir) for this lot has been received.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 (b)(4) and capa (b)(4).

• Brand Name: 1 SERIES ULTRA CARTRIDGE
• 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: 9556245
• MDR Text Key: 176435774
• Report Number: 2648035-2020-00017
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474534605
• UDI-Public: (01)05050474534605(17)200129(10)CE01187
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2020
• Device Model Number: 1VIPR30
• Device Catalogue Number: 1VIPR30
• Device Lot Number: CE01187
• 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
• Patient Outcome(s): Other