CVS RPG CONTACT LENS CLEANER ITEM #807750

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-02 for CVS RPG CONTACT LENS CLEANER ITEM #807750 manufactured by Cvs.

Event Text Entries

[40211431] Cvs rgp cleaner, item #807750 was recalled. I tried to buy it at several stores in (b)(6). On "(b)(6) 2016", i was told by the (b)(6), it was out of stock. I spent an hour the following friday going to the (b)(6). They had one cleaner on the shelf (even though it was recalled). I wanted two. They also said they were out of stock (they said they would have it by friday). They called the (b)(6) in (b)(6). (b)(6) set 2 of the lens cleaners aside for me. I took an half hour to drive there to pick up the cleaners. They refused to sell the two items to me because they said there was a recall. I would like to know why none of the stores had info on the recall to let me know about it. It is scary that the products that you clean contact lens with have been recalled. You are ultimately putting that lens in your eye. No store knew there was a recall that may have affected my use of the lens cleaner. My understanding is that the recall took place mid february. I sure hope you regulate this product because your person, (b)(6) told me you do and that i should fill out this form.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5060761
MDR Report Key5483079
Date Received2016-03-02
Date of Report2016-03-02
Date of Event2016-02-23
Date Added to Maude2016-03-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCVS RPG CONTACT LENS CLEANER ITEM #807750
Generic NameCVS RPG CONTACT LENS CLEANER
Product CodeHPX
Date Received2016-03-02
ID Number807750
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCVS


Patients

Patient NumberTreatmentOutcomeDate
10 2016-03-02

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