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	08/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two days following light treatment, patient noted a decrease in acuity and quality of vision.Examination confirmed a decrease in bcva.Retroillumination noted a defect near the center of the lens consistent with premature photopolymerization of the lens.Device history record for the lens was reviewed.No issues were noted.The patient's uv protective wear were returned for evaluation.No issues were noted with the uv spectacles.The uv spectacles were tested and found to be meet all specifications.The explanted lens has been returned and is currently being evaluated.
Event or Problem Description
Two days following light treatment, patient noted a decrease in acuity and quality of vision.Examination confirmed a decrease in bcva.Retroillumination noted a defect near the center of the lens consistent with premature photopolymerization of the lens.
Additional Manufacturer Narrative
Inspection and evaluation of the returned lens confirmed the presence of a zone on the anterior surface of the lens.The zone is indicative of premature photopolymerization.

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• MDR Report Key: 10522405
• Report Number: 3012712027-2020-00016
• Device Sequence Number: 11432850
• Product Code: HQL
• UDI-Device Identifier: 00818806020142
• UDI-Public: 010081880602014217220930
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• 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): 09/11/2020

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: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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