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	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bilateral patient reported issues with halos and glare.The patient reported spending time outdoors without wearing uv protective wear.Both lenses were explanted (left eye on (b)(6) 2020, right eye on (b)(6) 2020).Rxsight's first awareness date was (b)(6) 2020.Device history record for both lenses (serial numbers (b)(4) for the left eye and (b)(4) for the right eye) were reviewed.No issues were noted.For lens serial number (b)(4) (left eye): implanted: (b)(6) 2020, explanted: (b)(6) 2020, udi: (b)(4), manufactured: 10/21/2019, expiration date: 9/30/2022.For lens serial number (b)(4) (right eye): implanted: (b)(6) 2020, explanted: (b)(6) 2020, udi: (b)(4), manufactured: 10/12/2019, expiration date: 9/30/2022.Both lenses are being returned for evaluation.
Event or Problem Description
Bilateral patient reported issues with halos and glare.The patient reported spending time outdoors without wearing uv protective wear.Both lenses were explanted (left eye on (b)(6) 2020, right eye on (b)(6) 2020).Rxsight's first awareness date was (b)(6) 2020.
Additional Manufacturer Narrative
Bilateral patient reported issues with halos and glare.The patient reported spending time outdoors without wearing uv protective wear.Both lenses were explanted (left eye on (b)(6) 2020, right eye on (b)(6) 2020).Rxsight's first awareness date was (b)(6) 2020.Evaluation of the returned lenses noted an ambient zone near the center of one lens.The ambient zone is indicative of premature photopolymerization of the lens.
Event or Problem Description
Bilateral patient reported issues with halos and glare.The patient reported spending time outdoors without wearing uv protective wear.Both lenses were explanted (left eye on (b)(6) 2020, right eye on (b)(6) 2020).Rxsight's first awareness date 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: 10590446
• Report Number: 3012712027-2020-00019
• Device Sequence Number: 16470751
• Product Code: PZK
• UDI-Device Identifier: 00818806020180
• UDI-Public: 010081880602018017220930
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/25/2020

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: 09/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/25/2020
• 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
• Patient Age: 77 YR