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

Model Number	0030-4864
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Application support manager calculated the pre and post ks, noting overflattening of 1.31d (diopters) right eye (od) and 1.05d left eye (os).H3-81: 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
Customer reported patient outcome was overcorrected post photorefractive keratectomy in right eye (od), lasik in left eye (os) from procedure completed in (b)(6) 2020.Photorefractive keratectomy right eye was performed years ago in another facility due to incomplete flap.Per follow-up, patient was enhanced on 12/10/2020.Patient is doing great same day postop, 20/50 photorefractive keratectomy (prk) eye, 20/20 lasik eye.
Additional Manufacturer Narrative
Correction : h4: manufacturing date: the manufacturing site reported, that the correct manufacturing date for the device is 9/7/2010.Additional information: h3: device evaluated; h6: type of investigation and investigation findings, updated product investigation was completed.Device evaluation: a review of the records related to this equipment that included labeling, manual, trending, and risk documentation reviews for this equipment were performed.Equipment labeling provides possible complications, that can be caused by the surgical/treatment procedure being performed.The trend review shows, that 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.There was no product deficiency identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 11174972
• Report Number: 2020664-2021-07002
• Device Sequence Number: 2231615
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/07/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR