MAUDE Adverse Event Report: RXSIGHT, INC. LIGHT ADJUSTABLE LENS (LAL); LIGHT ADJUSTABLE LENS (LAL0

Model Number	60005
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The site reported that a patient had been implanted with a light adjustable lens, but did not return for any follow-up light treatments.The patient also did not comply with uv protective eyewear.The patient returned approximately 6 months after cataract surgery with complaints of blurry vision.Premature photopolymerization of the lens was confirmed.The lens was explanted on (b)(6) 2021.Device history record for the lens was reviewed.No issues were noted.The lens was not saved after explant.The site discarded the lens.
Event or Problem Description
The site reported that a patient had been implanted with a light adjustable lens, but did not return for any follow-up light treatments.The patient also did not comply with uv protective eyewear.The patient returned approximately 6 months after cataract surgery with complaints of blurry vision.Premature photopolymerization of the lens was confirmed.The lens was explanted on (b)(6) 2021.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS (LAL0
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• MDR Report Key: 11902523
• Report Number: 3012712027-2021-00022
• Device Sequence Number: 4572068
• Product Code: PZK
• UDI-Device Identifier: 00818806020166
• UDI-Public: 010081880602016617220630
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

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 Expiration Date: 06/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/28/2021
• 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