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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RXSIGHT, INC. RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL); LIGHT ADJUSTABLE LENS (LAL)
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RXSIGHT, INC. RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL); LIGHT ADJUSTABLE LENS (LAL) Back to Search Results
Model Number 60005
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Capsular Bag Tear (2639)
Date of Event 11/18/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Physician reported that as lens was delivered into the eye, the leading haptic caught the anterior rhexis, resulting in a small tear of the anterior capsule.The device history record for the lens batch was reviewed.No issues were noted.The lens remains implanted in the patient's eye.
 
Event or Problem Description
Physician reported that as lens was delivered into the eye, the leading haptic caught the anterior rhexis, resulting in a small tear of the anterior capsule.
 
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Brand Name
RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)
Common Device Name
LIGHT ADJUSTABLE LENS (LAL)
Manufacturer (Section D)
RXSIGHT, INC.
100 columbia
aliso viejo CA 92656
MDR Report Key11016893
Report Number3012712027-2020-00042
Device Sequence Number2699807
Product Code PZK
UDI-Device Identifier00818806020265
UDI-Public01008188060202651120061917230531
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
P160055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 12/15/2020
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 Date05/31/2023
Device Model Number60005
Device Catalogue Number60005
Device Lot NumberL02-001687
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/18/2020
Initial Report FDA Received Date12/16/2020
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 Other;
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