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

Model Number 1MTEC30

Device Problems Failure to Eject (4010); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Lot #: unknown,not provided.Expiration date: unknown as lot number was not provided.Unique identifier number (udi#): a complete udi# is unknown as the lot# was not provided.If implanted, if explanted, give date: not applicable, cartridge is not an implantable device.Expiration date: unknown as lot number was not provided.Device evaluation: it was confirmed that only the suspect lens was returned.Since cartridge is not available, the complaint issue reported could not be verified.Product deficiency could not be determined.Manufacturing record review could not be performed since lot number is unknown.The complaint occurrences per lot/batch also could not be performed since lot number is unknown.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during insertion of a model zlb00 intraocular lens (iol), the lens got stuck in the 1mtec30 cartridge.It was stated that there was patient contact.Through follow-up it was learnt that the lens was partially delivered into the eye, and then it got stuck in the cartridge.There was no incision enlargement, vitrectomy, or sutures required.Only the iol involved in the event is being returned, not the cartridge.The patient is reported to be fine, surgery went well post-op.No other information was provided.

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: PLATINUM 1 SERIES
• 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: 8829543
• MDR Text Key: 153097669
• Report Number: 2648035-2019-00772
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: UNKNOWN
• 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
• Treatment: ZLB00, SERIAL NUMBER (B)(4)