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

Model Number	60005
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient did not wear the uv protective spectacles following cataract surgery, resulting in the central polymerization zone.Patient was under the impression the uv protective spectacles were not necessary and instead wore his own glasses and sunglasses.This was a result of a miscommunication between the treating team and the patient.Device history record for the lens was reviewed.No issues were noted with the device history record.
Event or Problem Description
Following successful cataract surgery and implantation of the light adjustable lens on (b)(6) 2019, the patient did not wear uv spectacles.As a result, a central polymerization zone was noted on the light adjustable lens during the exam.The lens was explanted on (b)(6) 2019 and a new light adjustable lens was implanted.

• 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: 8984166
• Report Number: 3012712027-2019-00002
• Device Sequence Number: 3275104
• Product Code: HQL
• UDI-Device Identifier: 00818806020135
• UDI-Public: 010081880602013517220131
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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: 01/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-000935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/10/2019
• 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: 68 YR