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 10/22/2020

Event Type  Injury  

Manufacturer Narrative

Patient admitted to not wearing post operative uv spectacles indoors after cataract surgery, resulting in premature photopolymerization of the lens.The surgeon explanted the lens and replaced with another light adjustable lens.Device history record for the lens was reviewed.No issues were noted.The explanted lens was returned for evaluation.Inspection of the returned lens confirmed the presence of a zone in the center of the lens which is indicative of premature photopolymerization of the lens.

Event Description

Patient admitted to not wearing post operative uv spectacles indoors after cataract surgery, resulting in premature photopolymerization of the lens.The surgeon explanted the lens and replaced with another light adjustable lens.

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer (Section G): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer Contact: yi young ; 100 columbia; aliso viejo, CA 92656
• MDR Report Key: 10857309
• MDR Text Key: 216844260
• Report Number: 3012712027-2020-00035
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00818806020227
• UDI-Public: 01008188060202271119112417221031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention