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	03/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Site reported bilateral patient had light adjustable lenses explanted as the patient was unhappy with the visual outcome.Another lal was implanted in the right eye during the exchange on (b)(6) 2022 and another lal was implanted in the left eye during the exchange on (b)(6) 2022.Rxsight's first awareness of the event occurred on (b)(6) 2022.The device history record for the lenses were reviewed.No issues were noted.Right eye: serial number: (b)(4), lot number: l02-001495, implant date: (b)(6) 2021, mfg date: 1/9/2020, expiration date: 12/31/2022, explant date: (b)(6) 2022, udi: (b)(4).Left eye: serial number: (b)(4), lot number: l02-001536, implant date: (b)(6) 2021, mfg date: 1/28/2020, expiration date: (b)(6) 2022, explant date: (b)(6) 2022, udi: (b)(4).The lenses are in the process of being returned for evaluation.
Event or Problem Description
Site reported bilateral patient had light adjustable lenses explanted as the patient was unhappy with the visual outcome.Another lal was implanted in the right eye during the exchange on (b)(6) 2022 and another lal was implanted in the left eye during the exchange on (b)(6) 2022.Rxsight's first awareness of the event occurred on (b)(6) 2022.
Event or Problem Description
Site reported bilateral patient had light adjustable lenses explanted as the patient was unhappy with the visual outcome.Another lal was implanted in the right eye during the exchange on (b)(6) 2022 and another lal was implanted in the left eye during the exchange on (b)(6) 2022.Rxsight's first awareness of the event occurred on (b)(6) 2022.
Additional Manufacturer Narrative
Site reported bilateral patient had light adjustable lenses explanted as the patient was unhappy with the visual outcome.Another lal was implanted in the right eye during the exchange on (b)(6) 2022 and another lal was implanted in the left eye during the exchange on (b)(6) 2022.Rxsight's first awareness of the event occurred on (b)(6) 2022.The lenses were not saved after explant.The site discarded the lenses.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS (LAL)
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer (Section G): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer Contact: kelli carrillo ; 100 columbia; aliso viejo, CA 92656
• MDR Report Key: 14654233
• Report Number: 3012712027-2022-00024
• Device Sequence Number: 4841944
• Product Code: PZK
• UDI-Device Identifier: 00818806020203
• UDI-Public: 01008188060202031120010917221231
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: 12/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male