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

Model Number	0110-3450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9824738
• Report Number: 3006695864-2020-00175
• Device Sequence Number: 3069020
• Product Code: HKO
• UDI-Device Identifier: 05050474651432
• UDI-Public: (01)05050474651432
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K000327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 10/25/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/03/2020; 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCIMER LASER SERIAL NUMBER (B)(6). ; EXCIMER LASER SERIAL NUMBER (B)(4)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005