MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. UNFOLDER CARTRIDGE; SURGICAL ADJUNCTS

Model Number 1MTEC30

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

Lot #: unknown as information was not provided.Expiration date: unknown as product lot number was not provided.Udi #: a complete udi # is unknown as product 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 product lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported during product handling and prior to insertion of zcb00 23.0 diopter intraocular lens (iol) the haptic was noticed bent and the cartridge was noticed to be damaged before being given to surgeon.It was reported the appropriate cartridge and injector was used, back-up iol was used, and there was no intervention or complications intra-op or post-op.A photograph was received confirming the cartridge tip was damaged.There was no patient contact, no serious patient injury, no medical complications, and there was no surgical intervention.No additional information was provided to johnson & johnson surgical vision.

Manufacturer Narrative

Device available for evaluation: yes, returned to manufacturer on: 05/02/2019.Device evaluated by manufacturer: yes.Device evaluation: the complaint product was received in its original packaging with the wheel case insert and a cartridge with no identification.Lubricant material residues were observed in the cartridge.Cartridge tip was damaged/deformed.The reported issue was verified.However, due to the condition in which the sample returned it is not possible to determine that the reported issue is related to the manufacturing process.Based on the analysis product quality deficiency could not be determined.Manufacturing records review: the manufacturing record cannot be reviewed since the cartridge lot number is unknown.Historical data analysis: the complaint history was not reviewed since the cartridge lot number is unknown.Labeling review: the labeling review could not be performed because the complaint product was not identified.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.

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 nr-0148919 and capa-010215.

• Brand Name: UNFOLDER 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: 8467240
• MDR Text Key: 140451980
• Report Number: 2648035-2019-00397
• 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,Followup
• Report Date: 01/01/2005,11/09/2020

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
• Device Operator: Health Professional
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 05/17/2019; 10/25/2020
• Supplement Dates FDA Received: 06/07/2019; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZCB00 IOL SERIAL NO.: (B)(4)