OPTI-FREE PUREMOIST REWETTING DROPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-17 for OPTI-FREE PUREMOIST REWETTING DROPS manufactured by Alcon Research, Llc - Aspex.

Event Text Entries

[183877010] The complaint sample has not returned for evaluation; the lot number is unknown. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[183877011] As initially reported by the health professional via literature on 19feb2020, it was reported that out of 76 patients 58 patients have experienced corneal inflammatory events (cie) which includes contact lens peripheral ulcer (clpu) and infiltrative keratitis (contact lens acute red eye, contact lens associated infiltrative keratitis, asymptomatic infiltrates, asymptomatic infiltrative keratitis, or scattered infiltrates). Mixed, conditions where two of the three listed above were present simultaneously. The outcome of the events were not reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1610287-2020-00016
MDR Report Key9844604
Report SourceHEALTH PROFESSIONAL,LITERATUR
Date Received2020-03-17
Date of Report2020-03-17
Date Mfgr Received2020-02-19
Date Added to Maude2020-03-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JONATHAN SCHLECH
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8175514979
Manufacturer G1ALCON RESEARCH, LLC - ASPEX
Manufacturer Street6201 SOUTH FREEWAY
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal Code76134
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameOPTI-FREE PUREMOIST REWETTING DROPS
Generic NameACCESSORIES, SOFT LENS PRODUCTS
Product CodeLPN
Date Received2020-03-17
Model NumberNA
Catalog NumberNA
Lot NumberASKU
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LLC - ASPEX
Manufacturer Address6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-17

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