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

Model Number 1MTEC30

Device Problems Break (1069); Device Damaged by Another Device (2915)

Patient Problem No Code Available (3191)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted, if explanted, give date: not applicable as this is not an implantable device.  (b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that surgeon had 4 cartridges which failed and required incision enlargement to implant intraocular lens.Reportedly the plunger rod went through the cartridge.This occurred 4 different times and each time cracked the cartridge.This report captures the event for 1 of 4 devices.A separate report is being submitted for each device.No further information provided.

Manufacturer Narrative

Device available for evaluation; returned to manufacturer on: 9/9/2019.Device evaluation: the product was returned to the manufacturing site for evaluation.Twenty-one unused cartridges were received in the original box.The cartridges were sealed with tyvek lids in their trays.The cartridge was evaluated under magnification.No damage was observed.The cartridge used on the surgical stage during the event reported was not received for evaluation; the reported issue could not be verified.Based on the analysis product quality deficiency could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications a search on complaints revealed four (4) additional investigations, for this manufacturing lot cb41217.The dfu (direction of use) provides clear and adequate instructions.There is no potential risk to product or patient safety.In addition, a customer notification letter was generated to re-emphasize following the dfu instructions for the use of the coated cartridges.The investigations revealed no product deficiencies.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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: 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: 9017880
• MDR Text Key: 158609536
• Report Number: 2648035-2019-00999
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)191024(10)CB41217
• Combination Product (y/n): Y
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2019
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CB41217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• 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
• Patient Outcome(s): Required Intervention