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

Model Number	0110-2261
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Keratitis (1944); Pain (1994); Visual Disturbances (2140)
Date of Event	10/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The clinic reported that a laser vision correction patient had surgery on (b)(6) 2017.At 3 day post op uncorrected visual acuity in right eye was 20/50 -1 with pinhole at 20/20-1 and left eye was 20/50-2 with pinhole at 20/30 +2.5 day post op uncorrected visual acuity right 20/30 -2 and left 20/25 +2 6 day post op uncorrected visual acuity right 20/20 and left 20/25 +-1 refraction right.75 x -0.50 x005 20/20 -1 left plano -.50 x 142 20/25 -1 2+ superficial punctate keratitis both eyes 11 day post op uncorrected visual acuity right 20/30 and left 20/30 +-1 refraction right 2.25 x -0.50 x 180 20/25-2 left 1.75 -.50 x 007 20/25 -2 inferior 1+ superficial punctate keratitis in both eyes quick taper on lotemax 4 times a day, for 3 days then discontinue and artificial tears every hour.18 day post op uncorrected visual acuity right 20/30-1 and left 20/30 -1 with horizontal diplopia refraction right 3.50 x -0.50 x 150 20/20 -1 left 1.75 -.50 x 005 20/25 -2 23 day post op ((b)(6) 2017) uncorrected visual acuity right 20/40 +2 and left 20/30 -1 refraction right 3.50 x -0.50 x 150 20/20 -1 left 1.75 -.50 x 005 20/25 -2 started clapiks (contact lens-assisted, pharmacologically induced keratosteepening) on (b)(6) 2017 after wearing clapiks patient states he is only wearing it in right eye as left was too painful and stop wearing it on (b)(6) 2017.Refraction right plano x -0.50 x 180 20/20 -1 left 1.75 -.50 x 017 20/20 stopped clapiks.On (b)(6) 2017 patient notes shadows mostly at near however, feels it is getting better.Uncorrected right 20/20-2 20/20 left refraction right.50 x -0.50 x 180 20/20 left.50 -.50 x 022 20/20 patient has no loss of best corrected visual acuity.This case is for the idesign system.A separate report is being submitted for the visx laser.
Additional Manufacturer Narrative
Initially reported device manufacturing date from 9/8/2017 to corrected device manufacturing date 5/23/2017.Device evaluation: a review of the records related to the device that included labeling, manuals, trending, and risk documentation was performed.The trend review shows that there is not significant change over historical complaint limits and no 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.There was no product deficiency identified.All pertinent information available to johnson and johnson surgical vision has been submitted.

• Brand Name: IDESIGN AWS SYSTEM
• Common Device Name: REFRACTIVE MEASUREMENT
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7329213
• Report Number: 3006695864-2018-00486
• Device Sequence Number: 16170618
• Product Code: HKO
• UDI-Device Identifier: 05050474591912
• UDI-Public: (01)05050474591912
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 04/16/2018

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: Physician
• Device Model Number: 0110-2261
• Device Catalogue Number: 0110-2261
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 04/16/2018
• 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: VISX 3885
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR