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

Model Number	60005
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient with prior history of yag capsulotomy had previous non-rx sight, single-piece acrylic lens removed on (b)(6) 2020 in left eye.The haptics of the single-piece acrylic lens were left within the capsular bag, and the light adjustable lens was implanted during the exchange, however the stability of the bag could not be verified.Light adjustable lens was noted to be dislocated on (b)(6) 2020.Patient was referred to a retinal specialist who performed scleral fixation of the light adjustable lens to resolve the issue.Following procedure, patient's eye is stable, and patient is happy with 20/20 vision.The device history record for the lens was reviewed.No issues were noted.The lens remains implanted within the patient's eye.No product was returned for evaluation.
Event or Problem Description
Patient with prior history of yag capsulotomy had previous non-rx sight, single-piece acrylic lens removed on (b)(6) 2020 in left eye.The haptics of the single-piece acrylic lens were left within the capsular bag and the light adjustable lens was implanted during the exchange, however the stability of the bag could not be verified.Light adjustable lens was noted to be dislocated on (b)(6) 2020.Patient was referred to a retinal specialist who performed scleral fixation of the light adjustable lens to resolve the issue.Following procedure, patient's eye is stable, and patient is happy with 20/20 vision.

• Brand Name: RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• MDR Report Key: 10659660
• Report Number: 3012712027-2020-00027
• Device Sequence Number: 3564422
• Product Code: HQL
• UDI-Device Identifier: 00818806020159
• UDI-Public: 01008188060201591119111017221031
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P160055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 60005
• Device Catalogue Number: 60005
• Device Lot Number: L02-001401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention