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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 04/29/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Site reported that the light adjustable lens was explanted as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's first awareness of the event was 7/15/2021.Device history record for the lens was reviewed.No issues were noted.There is no indication that the lens is available for return.
 
Event or Problem Description
Site reported that the light adjustable lens was explanted as the desired refractive outcome was not achieved after light adjustment treatments.Rxsight's first awareness of the event was 7/15/2021.
 
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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 Key12277656
Report Number3012712027-2021-00038
Device Sequence Number3112996
Product Code PZK
UDI-Device Identifier00818806020210
UDI-Public01008188060202101120011617221231
Combination Product (Y/N)N
Initial Reporter StateMT
Initial Reporter CountryUS
PMA/510(K) Number
P160055
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
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) 08/04/2021
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 Date12/31/2022
Device Model Number60005
Device Catalogue Number60005
Device Lot NumberL02-001510
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/15/2021
Initial Report FDA Received Date08/04/2021
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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