MAUDE Adverse Event Report: RXSIGHT, INC. RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL); INTRAOCULAR LENS

Model Number	60005
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	05/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient with a light adjustable lens in the left eye complained of blurry vision with lots of glare.Upon examination, a central island 2-3 mm in size was noted near the center of the lens, which is indicative of exposure to uv light.Upon follow-up it was noted that the patient was not compliant with uv spectacle wear.The lens was explanted on (b)(6) 2020 (rxsight became aware on 5/6/2020).The explanted lens was discarded at the site and will not be returned for evaluation.Device history record for the lens was reviewed.No issues were noted with the device history record.
Event or Problem Description
Patient with a light adjustable lens in the left eye complained of blurry vision with lots of glare.Upon examination, a central island 2-3 mm in size was noted near the center of the lens, which is indicative of exposure to uv light.Upon follow-up it was noted that the patient was not compliant with uv spectacle wear.The lens was explanted on (b)(6) 2020 (rxsight became aware on 5/6/2020).The explanted lens was discarded at the site.

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo, ca
• MDR Report Key: 10094278
• Report Number: 3012712027-2020-00005
• Device Sequence Number: 11647867
• Product Code: HQL
• UDI-Device Identifier: 00818806020227
• UDI-Public: 010081880602022717220930
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

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: No Information
• Device Expiration Date: 09/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001348
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 05/27/2020
• 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: 54 YR