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	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient implanted with light adjustable lens on (b)(6) 2020.Site reported that patient had premature photopolymerization of the lens.The lens was explanted on (b)(6) 2020 and another lal was implanted.Rx sight's first awareness of the event was 7/23/2020.No additional information was provided.Device history record for the lens was reviewed.No issues were noted.The explanted lens was returned for evaluation.Inspection and evaluation of the lens confirmed the presence of a zone on the anterior surface of the lens which is indicative of premature photopolymerization.
Event or Problem Description
Patient implanted with light adjustable lens on (b)(6) 2020.Site reported that patient had premature photopolymerization of the lens.The lens was explanted on (b)(6) 2020 and another lal was implanted.Rx sight's first awareness of the event was 7/23/2020.No additional information was provided.

• 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: 10438658
• Report Number: 3012712027-2020-00015
• Device Sequence Number: 19865805
• Product Code: HQL
• UDI-Device Identifier: 00818806020104
• UDI-Public: 010081880602010417220630
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

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: 06/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/21/2020
• 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