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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RXSIGHT, INC. LIGHT ADJUSTABLE LENS (LAL)
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RXSIGHT, INC. LIGHT ADJUSTABLE LENS (LAL) Back to Search Results
Model Number 60005
Medical Device Problem Code Optical Problem (3001)
Health Effect - Clinical Code Visual Impairment (2138)
Date of Event 06/10/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device history record for the lens was reviewed.No issues were noted.The lens was discarded by the customer.No lens is expected to be returned.
 
Event or Problem Description
Site reported that the light adjustable lens was explanted from the patient's right eye as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's first awareness of the event occurred on (b)(6) 2021.
 
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Brand Name
LIGHT ADJUSTABLE LENS (LAL)
Common Device Name
LIGHT ADJUSTABLE LENS (LAL)
Manufacturer (Section D)
RXSIGHT, INC.
100 columbia
aliso viejo CA 92656
MDR Report Key11305419
Report Number3012712027-2021-00005
Device Sequence Number19047199
Product Code PZK
UDI-Device Identifier00818806020142
UDI-Public010081880602014217220831
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P160055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 02/09/2021
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 Date08/31/2022
Device Model Number60005
Device Catalogue Number60005
Device Lot NumberL02-001332
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/14/2021
Initial Report FDA Received Date02/09/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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