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

Model Number	60005
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Visual Disturbances (2140)
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.Patient had a history of guttata, fuch's dystrophy, dry eye syndrome and posterior vitreous detachment (pvd) for both eyes (ou).Prior to the implant, the patient was given several opportunities to trial monovision with contact lenses.However, the patient did not tolerate monovision.The treating physician did not recommend monovision to the patient due to patient age and lack of experience with monovision.During light adjustment treatments, the patient requested additional myopia in the left eye.As seen in relevant tests the patient had good distance vision with the right eye and near vision with the left eye after the light treatments were completed.The patient returned to the clinic for several visits after the final lock-in.The last known measurements taken on (b)(6) 2022 for the patient were: right eye ucdva was 20/25+1 and left eye ucnva was j1 with, bcdva was 20/20 in both eyes.Patient complained of blurred vision for distance and intermediate.Manufacturer reference #: (b)(4).
Event or Problem Description
Rxsight received a medwatch report mw5112449 dated 10/03/2022.A patient stated that they had the light adjustable lenses (lals) implanted and they are "essentially visually impaired for distance vision".The patient had a history of complaints related to severe blurry vision for years prior to implantation of the lals and a history of not tolerating monovision correction.The right eye (od) was implanted on (b)(6) 2021 with lal serial number (b)(4).The left eye (os) was implanted on (b)(6) 2021 with lal serial number (b)(4).During light adjustment treatments, the patient requested additional myopia in the left eye.Refer to mfr report #: 3012712027-2022-00058 for information on the patient's left eye.

• 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: 15840884
• Report Number: 3012712027-2022-00057
• Device Sequence Number: 17637894
• Product Code: PZK
• UDI-Device Identifier: 00818806020210
• UDI-Public: 01008188060202101120120717231130
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2022

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: 11/30/2023
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2022
• Initial Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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: Other
• Patient Age: 48 YR
• Patient Sex: Female