MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC SIGNATURE DUAL PUMP PACK; PHACO TUBING

Model Number OPO73

Device Problem Restricted Flow rate (1248)

Patient Problem Eye Burn (2523)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

Device manufacturer date is unknown as the serial number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

During a cataract extraction procedure, a corneal burn occurred in the patient¿s operative eye when using the whitestar signature pro console and signature dual pump pack, model opo73.The corneal burn occurred during sculpt mode on a very dense hard cataract case.The surgery center indicated the irrigation segment seemed a little slow during the case.The surgeon indicated the corneal burn may have been related to the very dense cataract but was not sure.A suture was required to close the wound.This report is for the tubing pack.A separate report will be submitted for the phacofragmentation console.

Manufacturer Narrative

Expiration date 9/01/2021.Additional: manufacturer date 9/01/2018.Device available for evaluation? yes.Returned to manufacturer on: 2/11/2019.Device returned to manufacturer? yes.Device evaluation: the opo73 tubing pack lot# 60146533 was returned within its original packaging.Visual assessment was performed, and no obvious defect was found.Priming, irrigation, and aspiration test was completed, and all results were found within specifications.The reported event cannot be confirmed.Manufacturing record review: per manufacturing records review report, no related non-conformity or deviations were issued during manufacturing the tubing pack lot# 60146533.All devices met material, assembly and performance specifications at the time of product released.Conclusion: based on the investigation results 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: SIGNATURE DUAL PUMP PACK
• Type of Device: PHACO TUBING
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 8258984
• MDR Text Key: 133459085
• Report Number: 3006695864-2019-00033
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474602083
• UDI-Public: (01)05050474602083(17)210901(10)60146533
• Combination Product (y/n): Y
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: 60146533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• 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
• Treatment: SIGNATURE PRO CONSOLE SERIAL NO: (B)(6).
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR