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	09/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for the manufacturing lot was reviewed and there were no discrepancies or unusual findings.After implant of the lal and prior to initiation of ldd light treatments, the patient had a superficial keratectomy (sk) performed.The patient's manifest refraction (mr) before lock-in #2 was plano.Approximately 2 months after lock-in #2, the patient's mr was +1.00 +1.75x 170, best corrected visual acuity (bcva) 20/20, and uncorrected visual acuity (ucva) 20/60.It is not known what the impact of the sk surgery was on the post-lock-in#2 refractive outcome.The treating physician thought the best option to help with the patient's ucva of 20/60 was to exchange the lal and perform light treatments again.On (b)(6) 2022, the original lal was explanted, and another lal was implanted.The explanted lens (sn: (b)(4) is in the process of being returned to rxsight.Manufacturer reference #: (b)(4).
Event or Problem Description
The site reported that a light adjustable lens (lal) has been explanted due to a hyperopic outcome.Rxsight's first awareness of the event was (b)(6) 2022.

• 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: jim zhang ; 100 columbia; aliso viejo, CA 92656 ; 9492736163
• MDR Report Key: 15655619
• Report Number: 3012712027-2022-00048
• Device Sequence Number: 2428591
• Product Code: PZK
• UDI-Device Identifier: 00818806020616
• UDI-Public: 01008188060206161122021417250131
• 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 Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2022

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: 01/31/2025
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L07-003683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• 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 Age: 68 YR
• Patient Sex: Female