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

Model Number	60005
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record for the lens was reviewed.No issues were noted.The lens has been returned and is currently being evaluated.
Event or Problem Description
Site reported 10 diopter lens was implanted into the left eye and the patient was +4.00 postoperatively and remained hyperopic following light treatments.The lens was explanted and a 15 diopter lal was implanted on (b)(6) 2021.Rxsight's first awareness of the event occurred on (b)(6) 2021.
Additional Manufacturer Narrative
Site reported, 10 diopter lens was implanted into the left eye.And the patient was +4.00 postoperatively.And remained hyperopic following light treatments.The lens was explanted, and a 15 diopter lal was implanted on (b)(6) 2021.Rxsight's first awareness of the event occurred on (b)(6) 2021.The lens was returned for evaluation.Visual inspection confirmed, that only half of the lens was returned for evaluation.No issues relating to the reported issue were noted.
Event or Problem Description
Site reported, 10 diopter lens was implanted into the left eye.And the patient was +4.00 postoperatively.And remained hyperopic following light treatments.The lens was explanted.And a 15 diopter lal was implanted on (b)(6) 2021.Rxsight's first awareness of the event occurred on (b)(6) 2021.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS (LAL)
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• MDR Report Key: 11319754
• Report Number: 3012712027-2021-00006
• Device Sequence Number: 16322547
• Product Code: PZK
• UDI-Device Identifier: 00818806020036
• UDI-Public: 010081880602003617220731
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2021
• 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): 02/11/2021

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: 07/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/02/2021
• 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