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 09/21/2020

Event Type  Injury  

Manufacturer Narrative

Patient reported to have spent time indoors by windows without uv protective eyewear resulting in decreased visual acuity in the left eye.Premature photopolymerization confirmed, resulting in explant of the lens.Device history record for the lens was reviewed.No issues were noted.The site visually confirmed the premature photopolymerization of the lens through slit lamp examination.The site noted that the explanted lens was too fragmented to be returned.

Event Description

Patient reported to have spent time indoors by windows without uv protective eyewear resulting in decreased visual acuity in the left eye.Premature photopolymerization confirmed, resulting in explant of the 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: 10659106
• MDR Text Key: 210711041
• Report Number: 3012712027-2020-00025
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00818806020142
• UDI-Public: 010081880602014217220930
• 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,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• 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: L02-001375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2019
• 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