MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. STAR; EXCIMER LASER

Model Number 0030-2505

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Code Available (3191)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

Sex/gender: unknown/ not provided.(b)(6).(b)(4).Investigation results the laser system, model star, was examined and tested at the customer location by an jjsv field service specialist (fss).The fss replaced chair mains cable.Replaced vacuum pillow line tubing.Ran a check disk on the hard drive, fixed errors as a result.Started the system a number of times, all went ok.Lastly was checked the system performance.System meets johnson and johnson vision specifications.A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, service history, and trending was reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.The review of the device history record (dhr) for star laser system showed that there were no issues or non-conformities.The system and its components met all specifications prior to being released.Manufacturing has been ruled out as a potential cause for the reported issue.Based on the investigation results, no corrective action has been issued.Based on the investigation results there is no indication of a product quality deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

It was reported that during a treatment with excimer laser system, machine gave a bed not in locked position error for twenty seconds during the procedure of the first eye of the patient.After follow-up we learned that this error was followed by numerous of other different unknown errors.Moreover surgeon was unable to get the laser back functioning and had to abandon the treatment.The patient was released and sent home with a bandaged contact lens on the eye.Routine eye drops were given for four days.A new treatment was performed few days later and all went well.Surgeon expected a normal recovery.

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: STAR
• Type of Device: EXCIMER LASER
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10314235
• MDR Text Key: 200240342
• Report Number: 3006695864-2020-00354
• Device Sequence Number: 1
• Product Code: LZS
• UDI-Device Identifier: 00(01)(21)5056
• UDI-Public: (01)(21)5056
• Combination Product (y/n): Y
• PMA/PMN Number: P930016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0030-2505
• Was Device Available for Evaluation?: Yes
• 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
• Patient Age: 21 YR