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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REVISION OPTICS RAINDROP NEAR VISION INLAY; CORNEAL INLAY
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REVISION OPTICS RAINDROP NEAR VISION INLAY; CORNEAL INLAY Back to Search Results
Model Number 610-0001
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Visual Disturbances (2140); Halo (2227)
Date of Event 12/11/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The product investigation is underway.The device history record review of the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Glare and halos are listed in the device labeling as known potential risks.Complaint reference number: (b)(4).
 
Event or Problem Description
The patient underwent uneventful implantation of the raindrop corneal inlay in the left eye on (b)(6) 2016.The inlay was explanted on (b)(6) , 2017 due to moderate-to-significant glare and halos.At last examination one day post explant, the visual symptoms had improved.
 
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Brand Name
RAINDROP NEAR VISION INLAY
Common Device Name
CORNEAL INLAY
Manufacturer (Section D)
REVISION OPTICS
25651 atlantic ocean dr.,
ste. a1
lake forest CA 92630 8835
MDR Report Key7165218
Report Number3005956347-2018-00007
Device Sequence Number11124485
Product Code LQE
UDI-Device Identifier10850394006013
UDI-Public(01)10850394006013
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P150034
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/04/2018
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 Physician
Device Expiration Date08/08/2019
Device Model Number610-0001
Device Catalogue NumberRD1-1
Device Lot Number002979
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/06/2017
Initial Report FDA Received Date01/04/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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