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

Model Number	60005
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient reported a decrease in visual acuity, resulting in lens being explanted after lock-in.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
Patient reported a decrease in visual acuity, resulting in lens being explanted after lock-in.
Additional Manufacturer Narrative
Patient reported a decrease in visual acuity, resulting in lens being explanted after lock-in.The explanted lens was returned for evaluation.The lens was received in multiple fragments.Optical testing found no issues with the optical quality of the lens.
Event or Problem Description
Patient reported a decrease in visual acuity, resulting in lens being explanted after lock-in.

• 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: 10590387
• Report Number: 3012712027-2020-00018
• Device Sequence Number: 2350139
• Product Code: PZK
• UDI-Device Identifier: 00818806020296
• UDI-Public: 010081880602029617220630
• 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: 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: 06/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• 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: 01/07/2021
• 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
• Patient Age: 51 YR