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	04/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted lens is expected to be returned for evaluation.The lens is currently in transit back to manufacturer.Device history record for the lens was reviewed.No issues were noted with the device history record.
Event or Problem Description
Patient reported to have uneventful implantation of the light adjustable lens on (b)(6) 2018.Lens adjustment and lock-in light treatments were performed with the patient's iris not fully dilated.This resulted in an incomplete adjustment and lock-in of the lens.After completion of the lock-in procedure, the patient stopped wearing the uv protective eyewear, causing the lens to continue to polymerize.The polymerization resulted in poor visual acuity and visual disturbances (ghosting).The lens was explanted on (b)(6) 2019.
Additional Manufacturer Narrative
The explanted lens was returned on 05/08/2019.Visual inspection and interferogram of the lens confirmed the additional polymerization of the lens following completion of the lock-in procedure.Coupled with the review of the clinical data and review of the adjustment and lock-in treatment videos, the root cause of the issue was determined to be due to insufficient uv exposure to consume the photoreactive components to adequately complete lal lock-in.The insufficient exposure was due to insufficient pupil dilation.

• 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: 8570808
• Report Number: 3012712027-2019-00001
• Device Sequence Number: 14001052
• Product Code: HQL
• UDI-Device Identifier: 00818806020173
• UDI-Public: 010081880602017317210331
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: 03/31/2021
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-0000318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 05/15/2019
• 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