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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 Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/01/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The device history record review of the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Inlay shifts in position is listed in the device labeling as a known potential risk.(b)(4).
 
Event or Problem Description
The patient underwent implantation of the raindrop corneal inlay in the left eye on (b)(6) 2017.On (b)(6) 2017, the inlay was exchanged due to decentration.Additional information has been requested.
 
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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 Key7149832
Report Number3005956347-2017-00171
Device Sequence Number1475849
Product Code LQE
UDI-Device Identifier10850394006013
UDI-Public(01)10850394006013
Combination Product (Y/N)N
Initial Reporter StateSD
Initial Reporter CountryUS
PMA/510(K) Number
P150034
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Physician
Device Expiration Date08/25/2020
Device Model Number610-0001
Device Catalogue NumberRD1-1
Device Lot Number003179
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/01/2017
Initial Report FDA Received Date12/27/2017
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 Hospitalization;
Patient Age54 YR
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