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

Model Number	1VIPR30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.
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).

• Brand Name: 1 SERIES ULTRA CARTRIDGE
• 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: 9556245
• Report Number: 2648035-2020-00017
• Device Sequence Number: 3229607
• Product Code: KYB
• UDI-Device Identifier: 05050474534605
• UDI-Public: (01)05050474534605(17)200129(10)CE01187
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K961242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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?: No
• Operator of Device: 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/07/2019
• Supplement Date Received by Manufacturer: 01/23/2020; 10/25/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 01/24/2020; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005