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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 Device Dislodged or Dislocated (2923)
Patient Problem Loss of Vision (2139)
Event Date 12/27/2017
Event Type  Injury  
Manufacturer Narrative
The explanted corneal inlay was lost during handling and was therefore not available for evaluation.The device history record review of the manufacturing lot for this device was performed and there were no discrepancies or unusual findings related to the reported issue.Inlay shifts in position and decreased vision are listed in the device labeling as known potential risks.(b)(4).
 
Event Description
The patient underwent implantation of the raindrop corneal inlay in the right eye on (b)(6) 2017.Postoperatively the inlay decentered 2 mm inferiorly.In addition, the patient's best corrected distance visual acuity (bcdva) decreased from 20/20 (preoperatively) to 20/30 immediately prior to inlay explantation on (b)(6) 2017.According to the surgeon, poor fixation during surgery was a contributing factor.At last examination on (b)(6) 2018, bcdva improved to 20/20 with a bandage contact lens in place and the patient was reported as stable.
 
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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 Key7202701
MDR Text Key97633924
Report Number3005956347-2018-00013
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 Physician
Type of Report Initial
Report Date 01/17/2018
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? Yes
Device Operator Physician
Device Expiration Date05/12/2020
Device Model Number610-0001
Device Catalogue NumberRD1-1
Device Lot Number003132
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/19/2017
Initial Date FDA Received01/17/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/12/2017
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;
Patient Age48 YR
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