MAUDE Adverse Event Report: RXSIGHT, INC. RXSIGHT LIGHT ADJUSTABLE LENS; INTRAOCULAR LENS

Model Number	60005
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bilateral patient implanted with the light adjustable lens ((b)(6) 2020 for left eye; (b)(6) 2020 for right eye).Patient was in the middle of light treatments for both eyes when covid-19 impacted the patient and prevented the patient from visiting the clinic to complete light treatments.Upon return to the clinic 2 months later, patient's visual acuity had decreased.The patient did not maintain compliance with uv spectacle wear during the prolonged interval caused by covid-19 interruption of clinical services.Both lenses were explanted on (b)(6) 2020 and replaced with new light adjustable lenses.Device history record for both lenses were reviewed.No issues were noted.Lens for the right eye (serial number (b)(4); manufactured 6/22/2019; expiration date 5/31/2022) was returned for evaluation.Visual inspection and optical path difference confirmed presence of premature photopolymerization.Lens for the left eye (serial number (b)(4); manufactured 9/24/2019; expiration date 8/31/2022) was not returned for evaluation.The site did provide a photo of the lens prior to explant which confirmed premature photopolymerization.
Event or Problem Description
Bilateral patient implanted with the light adjustable lens ((b)(6) 2020 for left eye; (b)(6) 2020 for right eye).Patient was in the middle of light treatments for both eyes when covid-19 impacted the patient and prevented the patient from visiting the clinic to complete light treatments.Upon return to the clinic 2 months later, patient's visual acuity had decreased.The patient did not maintain compliance with uv spectacle wear during the prolonged interval caused by covid-19 interruption of clinical services.Both lenses were explanted on (b)(6) 2020 and replaced with new light adjustable lenses.

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo, ca
• MDR Report Key: 10311256
• Report Number: 3012712027-2020-00011
• Device Sequence Number: 804646
• Product Code: HQL
• UDI-Device Identifier: 00818806020166
• UDI-Public: 010081880602016617220531
• Combination Product (Y/N): N
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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: 05/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001145, L02-001319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/22/2020
• 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
• Patient Age: 71 YR