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

Model Number	60005
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After second adjustment, but prior to lock-in, patient did not continue to wear the provided uv protective eyewear after misunderstanding instructions.Patient took an outdoor excursion on a bright day without provided uv protective eyewear and reported a decrease in vision the following day due to the unanticipated polymerization of the lens.The polymerization resulted in decreased visual acuity and visual disturbances (glare and halo), particularly in the left eye.The lens was explanted on (b)(6) 2019 and manufacturer was made aware of event on 2/6/2020.The site indicated that the lens was not available for return.Device history record for the lens was reviewed.No issues were noted with the device history record.
Event or Problem Description
Patient underwent uneventful implantation of the light adjustable lens on (b)(6) 2019.Patient underwent first and second adjustments without problems.After second adjustment, patient did not continue to wear the provided uv protective eyewear after misunderstanding instructions.Patient took an outdoor excursion on a bright day without provided uv protective eyewear and reported a decrease in vision the following day due to the unanticipated polymerization of the lens.The polymerization resulted in decreased visual acuity and visual disturbances (glare and halo), particularly in the left eye.The lens was explanted on (b)(6) 2019 and manufacturer was made aware of event on 2/6/2020.

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• MDR Report Key: 9683210
• Report Number: 3012712027-2020-00001
• Device Sequence Number: 2469418
• Product Code: HQL
• UDI-Device Identifier: 00818806020227
• UDI-Public: 010081880602022717211231
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2020

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: 12/31/2021
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-000883
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/07/2020
• 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: 63 YR