MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. IDESIGN AWS SYSTEM; REFRACTIVE MEASUREMENT

Model Number 0110-3450

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

The device manufacture date was not available at the time of this report.((b)(4).The system was evaluated by a field service engineer.The field service found no issues with the unit.A field service checklist was performed.The unit complied with all factory settings.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a laser vision correction patient had surgery on (b)(6) 2020 which resulted in 2 diopters of induced astigmatism in the right eye.The patient was iol implant.The case was photorefractive keratectomy (prk) utilizing amoils brush to remove epithelium.Pre op manifest: -2.50 +4.25 x 100.This report is for the idesign.A separate report will be filed for the excimer laser.

Manufacturer Narrative

H4: in initial report, the manufacturer date was not available and the manufacturing date is 04/15/2019.H3-81: an application support manager (asm) followed up with account and reported that the patient is seeing well.Asm instructed technicians on the proper way of inputting k values when not using the idesign populated k's.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: IDESIGN AWS SYSTEM
• Type of Device: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9824738
• MDR Text Key: 183162118
• Report Number: 3006695864-2020-00175
• Device Sequence Number: 1
• Product Code: HKO
• UDI-Device Identifier: 05050474651432
• UDI-Public: (01)05050474651432
• Combination Product (y/n): Y
• PMA/PMN Number: K000327
• 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: 01/01/2005,11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0110-3450
• Device Catalogue Number: 0110-3450
• 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
• Treatment: EXCIMER LASER SERIAL NUMBER (B)(6). ; EXCIMER LASER SERIAL NUMBER (B)(4)
• Patient Outcome(s): Other
• Patient Age: 82 YR