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 07/21/2020

Event Type  Injury  

Manufacturer Narrative

Patient implanted with light adjustable lens on (b)(6) 2020.Site reported that patient had premature photopolymerization of the lens.The lens was explanted on (b)(6) 2020 and another lal was implanted.Rx sight's first awareness of the event was 7/23/2020.No additional information was provided.Device history record for the lens was reviewed.No issues were noted.The explanted lens was returned for evaluation.Inspection and evaluation of the lens confirmed the presence of a zone on the anterior surface of the lens which is indicative of premature photopolymerization.

Event Description

Patient implanted with light adjustable lens on (b)(6) 2020.Site reported that patient had premature photopolymerization of the lens.The lens was explanted on (b)(6) 2020 and another lal was implanted.Rx sight's first awareness of the event was 7/23/2020.No additional information was provided.

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo, ca
• Manufacturer (Section G): RXSIGHT, INC.; 100 columbia; aliso viejo, ca
• Manufacturer Contact: yi young ; 100 columbia; aliso viejo, ca
• MDR Report Key: 10438658
• MDR Text Key: 210690701
• Report Number: 3012712027-2020-00015
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00818806020104
• UDI-Public: 010081880602010417220630
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2019
• 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