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

Model Number	60005
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	10/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bilateral patient reported to have premature photopolymerization of the light adjustable lens implanted in patient's eyes.One eye was explanted on (b)(6) 2020 and the second eye was explanted on (b)(6) 2020.Rxsight's awareness was 10/31/2020.Device history record for the lenses were reviewed.No issues were noted.Right eye: serial number: (b)(4), implant date: (b)(6) 2020, manufacturing date: 11/12/2019, expiration date: 10/31/2022, udi: (b)(4).Left eye: serial number: (b)(4), implant date: (b)(6) 2020, manufacturing date: 10/28/2019, expiration date: 9/30/2020, udi: (b)(4).The explanted lenses are in process of being returned for evaluation.
Event or Problem Description
Bilateral patient reported to have premature photopolymerization of the light adjustable lens implanted in patient's eyes.One eye was explanted on (b)(6) 2020 and the second eye was explanted on (b)(6) 2020.Rxsight's awareness was 10/31/2020.
Event or Problem Description
Bilateral patient reported to have premature photopolymerization of the light adjustable lens implanted in patient's eyes.One eye was explanted on (b)(6) 2020 and the second eye was explanted on (b)(6) 2020.
Additional Manufacturer Narrative
Bilateral patient reported to have premature photopolymerization of the light adjustable lens implanted in patient's eyes.One eye was explanted on (b)(6) 2020 and the second eye was explanted on (b)(6) 2020.The explanted lenses were returned for evaluation.Visual inspection confirmed the presence of a zone in the center of the lenses which is indicative of premature photopolymerization of the lenses.

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)
• Common Device Name: LIGHT ADJUSTABLE LENS (LAL)
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• MDR Report Key: 10980206
• Report Number: 3012712027-2020-00040
• Device Sequence Number: 16338376
• Product Code: PZK
• UDI-Device Identifier: 00818806020166
• UDI-Public: 01008188060201661119111217221031
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/09/2020

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: 10/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Received by Manufacturer: 10/31/2020
• Supplement Date Received by Manufacturer: 10/31/2020
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 02/09/2021
• 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