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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RXSIGHT, INC. RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL); INTRAOCULAR LENS
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RXSIGHT, INC. RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL); INTRAOCULAR LENS Back to Search Results
Model Number 60005
Device Problem Misfocusing (1401)
Patient Problem Blurred Vision (2137)
Event Date 08/25/2020
Event Type  Injury  
Manufacturer Narrative
Doctor entered the incorrect target for the light delivery device.The light delivery device adjusted the lens to the target as specified by the doctor, resulting in undesired refractive outcome for the patient.Device history record for the lens was reviewed.No issues were noted.The explanted lens has been returned and is currently being evaluated.
 
Event Description
Doctor entered the incorrect target for the light delivery device.The light delivery device adjusted the lens to the target as specified by the doctor, resulting in undesired refractive outcome for the patient.
 
Manufacturer Narrative
The explanted lens was returned.The lens was cut into several fragments, with some of the cuts going through the center of the optic.Due to the extent of damage to the lens, additional testing could not be performed.
 
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Brand Name
RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
RXSIGHT, INC.
100 columbia
aliso viejo CA 92656
MDR Report Key10581915
MDR Text Key208412768
Report Number3012712027-2020-00017
Device Sequence Number1
Product Code HQL
UDI-Device Identifier00818806020203
UDI-Public01008188060202031119110617221031
Combination Product (y/n)N
PMA/PMN Number
P160055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2022
Device Model Number60005
Device Catalogue Number60005
Device Lot NumberL02-001397
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Date Manufacturer Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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