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

Model Number	1VIPR30
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot #: unknown.Although the customer account provided two(02) cartridge lot numbers (cd10065 & cd10067), however it is unknown exactly which cartridge lot number was involved in the reported event.For emdr reporting purposes the event will be captured with an 1vipr30 cartridge unknown lot number.Expiration date: unknown as cartridge lot number was not provided.Udi #: a complete udi # is unknown as cartridge lot number was not provided.If implanted, give date: not applicable, as the cartridge is not an implantable device.If explanted, give date: not applicable, as the cartridge is not an implantable device.Device manufacture date: unknown as cartridge lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported 1vipr30 cartridge was split at the cartridge tip during insertion.It was reported the lens was not damaged and the patient was not injured.
Additional Manufacturer Narrative
Product lot number was provided, therefore the following fields have been updated: expiration date: updated from unknown to 09/12/2019 as product lot number information was provided.Udi #: updated from unknown to (b)(4) as product lot number information was provided.Device evaluated by manufacturer: yes , device manufacture date: updated from unknown to 09/12/2018 as product lot number information was provided.Device evaluation: a photo attached was provided in the complaint folder (cf).A photo attached was provided in the cf.Product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: during the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured and released according to specifications.Historical data analysis: a search of complaints revealed no additional investigation has been received for this production order number.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not 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-010215.

• 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: 8346378
• Report Number: 2648035-2019-00199
• Device Sequence Number: 1923782
• Product Code: KYB
• UDI-Device Identifier: 05050474534605
• UDI-Public: (01)05050474534605(10)UNKNOWN
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K961242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2019
• Device Model Number: 1VIPR30
• Device Catalogue Number: 1VIPR30
• Device Lot Number: CD10065
• 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: 01/21/2019
• Supplement Date Received by Manufacturer: 02/21/2019; 10/25/2020
• Initial Report FDA Received Date: 02/16/2019
• Supplement Report FDA Received Date: 03/20/2019; 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005