RAINDROP NEAR VISION INLAY 610-0001 RD1-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-01-24 for RAINDROP NEAR VISION INLAY 610-0001 RD1-1 manufactured by Revision Optics.

Event Text Entries

[98164059] The explanted inlay was discarded by the facility and 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, corneal inflammation, and epithelial ingrowth are listed in the device labeling as known potential risks. Complaint reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[98164060] The patient underwent implantation of the raindrop corneal inlay in the left eye on (b)(6) 2017. Within the first 2 postoperative weeks the patient presented with inferior inlay decentration and inlay repositioning was planned. During this procedure inflammation was observed in the interface in the area of the inlay, likely due to a corneal abrasion a few days prior. In addition, epithelial ingrowth was observed near the corneal flap hinge. On (b)(6) 2017, the inlay was explanted and a replacement inlay will be implanted once the inflammation resolves and the eye is stable. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005956347-2018-00017
MDR Report Key7217652
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-01-24
Date of Report2018-01-24
Date of Event2017-12-27
Date Mfgr Received2017-12-27
Device Manufacturer Date2017-06-28
Date Added to Maude2018-01-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. PUSHPITA SINGH
Manufacturer Street25651 ATLANTIC OCEAN DR., STE. A1
Manufacturer CityLAKE FOREST CA 926308835
Manufacturer CountryUS
Manufacturer Postal926308835
Manufacturer Phone9497072740
Manufacturer G1REVISION OPTICS
Manufacturer Street25651 ATLANTIC OCEAN DR., STE. A1
Manufacturer CityLAKE FOREST CA 926308835
Manufacturer CountryUS
Manufacturer Postal Code926308835
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRAINDROP NEAR VISION INLAY
Generic NameCORNEAL INLAY
Product CodeLQE
Date Received2018-01-24
Model Number610-0001
Catalog NumberRD1-1
Lot Number003166
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerREVISION OPTICS
Manufacturer Address25651 ATLANTIC OCEAN DR., STE. A1 LAKE FOREST CA 926308835 US 926308835


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2018-01-24

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