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

Model Number	60005
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Site reported that patient with history of radial keratotomy (rk) and photorefractive keratectomy (prk) had the light adjustable lens explanted from the left eye as the desired refractive outcome was not achieved after light adjustment treatments.The lens was explanted on (b)(6) 2020 (rxsight's first awareness was 10/29/2020).Device history record for the lens was reviewed.No issues were noted.The explanted lens has been returned, and is currently being evaluated.
Event or Problem Description
Site reported that patient with history of radial keratotomy (rk) and photorefractive keratectomy (prk) had the light adjustable lens explanted from the left eye as the desired refractive outcome was not achieved after light adjustment treatments.The lens was explanted on (b)(6) 2020 (rxsight's first awareness was 10/29/2020).
Additional Manufacturer Narrative
Site reported that patient with history of radial keratotomy (rk) and photorefractive keratectomy (prk) had the light adjustable lens explanted from the left eye as the desired refractive outcome was not achieved after light adjustment treatments.The lens was explanted on (b)(6) 2020 (rxsight's first awareness was (b)(6) 2020).Evaluation of the returned lens verified the lens had been cut into multiple pieces due to being explanted.Other than the damage to the lens, no visual or optical abnormalities were noted.
Event or Problem Description
Site reported that patient with history of radial keratotomy (rk) and photorefractive keratectomy (prk) had the light adjustable lens explanted from the left eye as the desired refractive outcome was not achieved after light adjustment treatments.The lens was explanted on (b)(6) 2020 (rxsight's first awareness was (b)(6) 2020).

• 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: 10907250
• Report Number: 3012712027-2020-00038
• Device Sequence Number: 3230214
• Product Code: PZK
• UDI-Device Identifier: 00818806020289
• UDI-Public: 010081880602028917220228
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: 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): 11/25/2020

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: 02/28/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-000992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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