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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS
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IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS Back to Search Results
Model Number VICM5 12.6
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Patient Involvement (2645)
Event Date 05/15/2020
Event Type  malfunction  
Manufacturer Narrative
This product is not marketed in the us.No similar complaint type events were reported for units within the same lot.(b)(4).
 
Event Description
The reporter indicated that a 12.6mm vicm512.6, -10.50 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2020.The lens tore during injection.There was no patient contact.During initial surgery on (b)(6) 2020, a replacement lens was implanted.This resolved the problem.Cause of the event is reported as user error.
 
Manufacturer Narrative
Additional information: h3- device evaluation: lens was returned in a micro centrifuge vial with debris on the lens.Visual inspection found the haptic torn and foreign debris on the lens.Claim# (b)(4).
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Type of Device
PHAKIC INTRAOCULAR LENS
MDR Report Key10271245
MDR Text Key201547085
Report Number2023826-2020-01492
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 06/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Model NumberVICM5 12.6
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2020
Initial Date Manufacturer Received 06/23/2020
Initial Date FDA Received07/14/2020
Supplement Dates Manufacturer Received08/17/2020
Supplement Dates FDA Received09/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARTRIDGE MODEL#SFC-45, LOT#1459823; FOAMTIPPLUNGER MODEL#FTP, LOT#1458699; INJECTOR MODEL#MSI-PF, LOT#1477601
Patient Age21 YR
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