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

Model Number 60005

Device Problem Optical Distortion (3000)

Patient Problem Visual Disturbances (2140)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

Two days following light treatment, patient noted a decrease in acuity and quality of vision.Examination confirmed a decrease in bcva.Retroillumination noted a defect near the center of the lens consistent with premature photopolymerization of the lens.Device history record for the lens was reviewed.No issues were noted.The patient's uv protective wear were returned for evaluation.No issues were noted with the uv spectacles.The uv spectacles were tested and found to be meet all specifications.The explanted lens has been returned and is currently being evaluated.

Event Description

Two days following light treatment, patient noted a decrease in acuity and quality of vision.Examination confirmed a decrease in bcva.Retroillumination noted a defect near the center of the lens consistent with premature photopolymerization of the lens.

Manufacturer Narrative

Inspection and evaluation of the returned lens confirmed the presence of a zone on the anterior surface of the lens.The zone is indicative of premature photopolymerization.

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• MDR Report Key: 10522405
• MDR Text Key: 206550714
• Report Number: 3012712027-2020-00016
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00818806020142
• UDI-Public: 010081880602014217220930
• Combination Product (y/n): N
• PMA/PMN Number: P160055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention