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

Model Number 1MTEC30

Device Problem Failure to Eject (4010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information: age/date of birth: unknown, information not provided.Expiration date: unknown, as lot number was not provided.Unique identifier: a complete udi# is unknown as the lot# 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 lot number not provided.Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified.Manufacturing record review: a review of the records could not be performed as the product lot number was not provided.Conclusion: based on the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a model zcb00 intraocular lens (iol) was damaged while inserting it into the operative eye.The lens had patient contact and was stuck in the cartridge.The procedure was completed with a backup iol of the same model and diopter.Reportedly, the patient is doing well.Through follow-up the customer clarified that the iol got stuck in the cartridge and was partially inserted.There were no complications such as incision enlargement, capsule tear vitrectomy or sutures.The cartridge lot number was not available.No further 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:(b)(4).

• 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: 10006470
• MDR Text Key: 189221779
• Report Number: 2648035-2020-00398
• 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: 01/01/2005,10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• 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: IOL ZCB00 13.5 DIOPTER SERIAL#: (B)(4); IOL ZCB00 13.5 DIOPTER SERIAL#: (B)(4)