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 08/25/2020

Event Type  Injury  

Manufacturer Narrative

Bilateral patient reported to have spent time outdoors without uv protective eyewear resulting in decreased visual acuity due to premature photopolymerization of both lenses.Right eye (implanted (b)(6) 2020) was explanted on (b)(6) 2020.Left eye (implanted (b)(6)2020) was explanted on (b)(6) 2020.Rxsight's first awareness date was (b)(6) 2020.Device history record for both lenses (serial numbers (b)(4) for the right eye and (b)(4) for the left eye) were reviewed.No issues were noted.For lens serial number (b)(4) (right eye), implanted: (b)(6) 2020, explanted: (b)(6) 2020, udi: (b)(4), manufactured: 3/19/2019, expiration date: 2/28/2022.For lens serial number (b)(4) (left eye), implanted: (b)(6) 2020, explanted: (b)(6) 2020, udi: (b)(4), manufactured: 5/17/2019, expiration date: 4/30/2022.The site visually confirmed the premature photopolymerization of the lenses through slit lamp examination.The site noted that the explanted lenses were too fragmented to be returned.

Event Description

Bilateral patient reported to have spent time outdoors without uv protective eyewear resulting in decreased visual acuity due to premature photopolymerization of both lenses.Right eye (implanted (b)(6) 2020) was explanted on (b)(6) 2020.Left eye (implanted (b)(6)2020) was explanted on (b)(6) 2020.Rxsight's first awareness date was (b)(6) 2020.

• 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: 10653303
• MDR Text Key: 210598718
• Report Number: 3012712027-2020-00024
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00818806020258
• UDI-Public: 010081880602025817190319
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001013
• 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: 03/19/2019
• 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