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

Model Number	60005
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The site reported that a bilateral patient had been implanted with a light adjustable lens, but did not return for any follow-up light treatments.The patient also did not comply with uv protective eyewear.The patient returned approximately 6 months after cataract surgery with complaints of blurry vision.Premature photopolymerization of the lens was confirmed.The lens in the right eye was explanted on (b)(6) 2021.The lens within the left eye was explanted on (b)(6) 2021 and was reported under 3012712027-2021-00022.Device history record for the lens was reviewed.No issues were noted.The lens is in process of being returned for evaluation.
Event or Problem Description
The site reported that a bilateral patient had been implanted with a light adjustable lens, but did not return for any follow-up light treatments.The patient also did not comply with uv protective eyewear.The patient returned approximately 6 months after cataract surgery with complaints of blurry vision.Premature photopolymerization of the lens was confirmed.The lens in the right eye was explanted on (b)(6) 2021.The lens within the left eye was explanted on (b)(6) 2021 and was reported under 3012712027-2021-00022.
Event or Problem Description
The site reported that a bilateral patient had been implanted with a light adjustable lens, but did not return for any follow-up light adjustment treatments.The patient also did not comply with uv protective eyewear.The patient returned approximately 6 months after cataract surgery with complaints of blurry vision.Premature photopolymerization of the lens was confirmed.The lens in the right eye was explanted on (b)(6) 2021.The lens within the left eye was explanted on (b)(6) 2021 and was reported under 3012712027-2021-00022.
Additional Manufacturer Narrative
The site reported that a bilateral patient had been implanted with a light adjustable lens, but did not return for any follow-up light adjustment treatments.The patient also did not comply with uv protective eyewear.The patient returned approximately 6 months after cataract surgery with complaints of blurry vision.Premature photopolymerization of the lens was confirmed.The lens in the right eye was explanted on (b)(6) 2021.The lens within the left eye was explanted on (b)(6) 2021 and was reported under 3012712027-2021-00022.The lens was not saved after explant.The site discarded the lens.

• Brand Name: LIGHT ADJUSTABLE LENS (LAL)
• Common Device Name: LIGHT ADJUSTABLE LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer (Section G): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer Contact: yi young ; 100 columbia; aliso viejo, CA 92656
• MDR Report Key: 12155296
• Report Number: 3012712027-2021-00029
• Device Sequence Number: 3774840
• Product Code: PZK
• UDI-Device Identifier: 00818806020159
• UDI-Public: 01008188060201591120030117230228
• 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: 2021
• 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): 07/12/2021

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: 02/28/2023
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001590
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2020
• 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