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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Corneal Clouding/Hazing (1878)
Event Date 12/22/2017
Event Type  Injury  
Manufacturer Narrative
The inlay remains implanted in the patient at this time and the device will be requested post explant.The device history record review of the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Corneal haze is listed in the device labeling as a known potential risk.Complaint reference number: (b)(4).
 
Event Description
The patient underwent implantation of the raindrop corneal inlay on (b)(6) 2017.Postoperatively, the patient has presented with dense central corneal haze and the inlay is scheduled to be explanted on (b)(6) 2018.Additional information has been requested.
 
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Brand Name
RAINDROP NEAR VISION INLAY
Type of Device
CORNEAL INLAY
Manufacturer (Section D)
REVISION OPTICS
25651 atlantic ocean dr.,
ste. a1
lake forest CA 92630 8835
Manufacturer (Section G)
REVISION OPTICS
25651 atlantic ocean dr.,
ste. a1
lake forest CA 92630 8835
Manufacturer Contact
pushpita singh
25651 atlantic ocean dr.,
ste. a1
lake forest, CA 92630-8835
9497072740
MDR Report Key7206931
MDR Text Key97790162
Report Number3005956347-2018-00015
Device Sequence Number1
Product Code LQE
UDI-Device Identifier10850394006013
UDI-Public(01)10850394006013
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150034
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 01/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Expiration Date08/22/2019
Device Model Number610-0001
Device Catalogue NumberRD1-1
Device Lot Number002984
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/22/2017
Initial Date FDA Received01/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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