MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. STAR S4 IR; EXCIMER LASER SYSTEM

Model Number	0030-4864
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Visual Disturbances (2140); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: unknown/ not provided.(b)(4).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 uncomplicated surgery on both eyes (ou) on (b)(6) 2021 and presented at 6 week post op visit with discomfort and photophobia.It was noted to have early flap melt at periphery right eye more than in left eye.Patient was started on durezol 4 times a day in both eyes.Symptoms improved quickly, but he developed an interface granularity inflammation at the area of flap thinning, extending centrally in right eye and trace inflammation inferotemporal flap edge in left eye.There was also epithelial ingrowth noted and it was recommended removal.Additional medications that were given was vigamox and pred forte.Vision remains excellent.

• Brand Name: STAR S4 IR
• Common Device Name: EXCIMER LASER SYSTEM
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 12595345
• Report Number: 2020664-2021-07672
• Device Sequence Number: 4220998
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P910062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: 0030-4864
• Device Catalogue Number: 0030-4864
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR