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

Model Number	1VIPR30
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Expiration date: unknown, as the lot number was not provided.Lot number: unknown, information not provided.Udi number: a partial udi number is known, as the lot number was not provided.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.Phone number: (b)(6).Device manufacture date: unknown as lot number was not provided.(b)(4).Device evaluation: the complaint sample was not returned to the manufacturing site; therefore, product testing could not be performed, and the customer's reported complaint could not be verified.Manufacturing record evaluation: manufacturing record review cannot be performed since the lot number is unknown.A search of complaints related to lot number cannot be performed since the lot number is unknown.Conclusion: no sample was returned, and lot number is unknown an investigation could not be performed, and no malfunction is confirmed.No escalation is required.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that during surgery the trailing haptic of an intraocular lens (iol) got stuck in the injector and broke.The surgeon removed the iol and completed the surgery with the standby lens of the same model lens but a different diopter (23.0) with the same injector and a different cartridge.There was a 30 minute delay in treatment which the incision was enlarged to cut and remove the lens from the eye.Sutures were required at the end of the surgery.It was reported that currently the patient does not have any complaint with the vision.No further information provided.

• 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: 11062197
• Report Number: 2648035-2020-00958
• Device Sequence Number: 2585560
• Product Code: KYB
• UDI-Device Identifier: 05050474534605
• UDI-Public: (01)05050474534605(10)UNKNOWN
• 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
• Report Date (Section B): 12/22/2020

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 Model Number: 1VIPR30
• Device Catalogue Number: 1VIPR30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/23/2020
• 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: LENS MODEL ICB00, SN (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention