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	02/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient underwent uneventful cataract surgery in both eyes in (b)(6) 2019.Patient returned approximately one month post-lock-in indicating that the vision in her right eye had changed.Left eye refraction remained unchanged.The patient's doctor elected to explant the lens and implant with another light adjustable lens.The manufacturer's first awareness of the explant was 2/29/2020.The explanted lens is in process of being returned for evaluation.Device history record for the lens was reviewed.No issues were noted with the device history record.
Event or Problem Description
Patient underwent uneventful cataract surgery in both eyes in (b)(6) 2019.Patient returned approximately one month post-lock-in indicating that the vision in her right eye had changed.Left eye refraction remained unchanged.The patient's doctor elected to explant the lens and implant with another light adjustable lens.The manufacturer's first awareness of the explant was 2/29/2020.
Event or Problem Description
Patient underwent uneventful cataract surgery in both eyes in (b)(6) 2019.All light treatments were performed and completed in (b)(6) 2019 without issue.In the right eye, uncorrected visual acuity was noted to range from 20/20 to 20/30 prior to each of the light treatments.In the left eye, uncorrected visual acuity was noted to range from 20/40 through 20/80 prior to each of the light treatments.Approximately one month after the final light treatment, the patient returned and indicated that the vision in her right eye had changed (uncorrected visual acuity was noted to be 20/60).The left eye was not reported as significantly changed (uncorrected visual acuity measured to be 20/50).The patient had previously received lasik in both eyes and was noted to have a decentered hyperopic ablation pattern.The doctor elected to explant the lens in the right eye and implant with another 22.5 diopter light adjustable lens.Following the lens exchange, the patient is doing well with an uncorrected visual acuity of 20/20.
Additional Manufacturer Narrative
Patient underwent uneventful cataract surgery in both eyes in (b)(6) 2019.All light treatments were performed and completed in (b)(6) 2019 without issue.In the right eye, uncorrected visual acuity was noted to range from 20/20 to 20/30 prior to each of the light treatments.In the left eye, uncorrected visual acuity was noted to range from 20/40 through 20/80 prior to each of the light treatments.Approximately one month after the final light treatment, the patient returned and indicated that the vision in her right eye had changed (uncorrected visual acuity was noted to be 20/60).The left eye was not reported as significantly changed (uncorrected visual acuity measured to be 20/50).The patient had previously received lasik in both eyes and was noted to have a decentered hyperopic ablation pattern.The doctor elected to explant the lens in the right eye and implant with another 22.5 diopter light adjustable lens.Following the lens exchange, the patient is doing well with an uncorrected visual acuity of 20/20.Device history record for the lens was reviewed.No issues were noted with the device history record.The explanted lens was received on 7/6/2020 cut into two large fragments.The cut was made through the center of the lens and was serrated/jagged.All options were exhausted to make useful measurements of the lens, but due to the lens damage, measurements could not be made.Based on the review of the information provided by the site and the device history record, there is no indication that the device malfunctioned.

• 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: 9892014
• Report Number: 3012712027-2020-00003
• Device Sequence Number: 2184654
• Product Code: HQL
• UDI-Device Identifier: 00818806020227
• UDI-Public: 010081880602022717220531
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 02/29/2020
• Supplement Date Received by Manufacturer: 02/29/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 07/15/2020
• 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