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 Code	Visual Disturbances (2140)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient with bilateral light adjustable lens implants (left eye on (b)(6) 2020; right eye on (b)(6) 2020).Patient reported visual disturbances and decrease in vision prior to adjustment procedure on (b)(6) 2020.The delay in starting light treatments were due to covid-19.Diagnostic testing confirmed decrease in visual acuity with the decrease in the left eye greater (bcdva 20/60) than the right eye (bcdva 20/32).Diagnostic testing also confirmed bilateral premature photopolymerization.It was reported that the patient was not compliant with uv protective wear.Surgeon elected to proceed with light treatments on the right eye and to explant the lens in the left eye.Lens (27.0 diopter) in left eye was explanted on (b)(6) 2020 and replaced with a toric lens (27.5 diopter).The site took slit lamp photos which confirmed the premature photopolymerization of the lens in the left eye.The explanted lens was returned for evaluation.Inspection of the returned lens fragments also confirmed the premature photopolymerization.Device history records for the lenses were reviewed.No issues were noted with the device history records.Left lens serial number (b)(4).Manufacturing date of 03/26/2019.Expiration date was 02/28/2022.Udi: (b)(4).Light adjustable lens adjustments normally begin approximately 17-21 days post-implantation.The lens was implanted on (b)(6) 2020, but the patient's appointment for the first adjustment was on (b)(6) 2020, over 60 days post-implantation.The delay was due to covid-19.This resulted in the patient needing to wear the uv protective wear for an extended period of time.
Event or Problem Description
Patient with bilateral light adjustable lens implants (left eye on (b)(6) 2020; right eye on (b)(6) 2020).Patient reported visual disturbances and decrease in vision prior to adjustment procedure on (b)(6) 2020.The delay in starting light treatments were due to covid-19.Diagnostic testing confirmed decrease in visual acuity with the decrease in the left eye greater (bcdva 20/60) than the right eye (bcdva 20/32).Diagnostic testing also confirmed bilateral premature photopolymerization.It was reported that the patient was not compliant with uv protective wear.Surgeon elected to proceed with light treatments on the right eye and to explant the lens in the left eye.Lens (27.0 diopter) in left eye was explanted on (b)(6) 2020 and replaced with a toric lens (27.5 diopter).

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo, ca
• MDR Report Key: 10268565
• Report Number: 3012712027-2020-00009
• Device Sequence Number: 16895221
• Product Code: HQL
• UDI-Device Identifier: 00818806020289
• UDI-Public: 010081880602028917220228
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 07/13/2020

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: 02/28/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/13/2020
• 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: 41 YR