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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS Back to Search Results
Model Number VICM5_13.2
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2020
Event Type  malfunction  
Manufacturer Narrative
This product is manufactured in the u.S.But not marketed in the u.S.No similar complaint type events reported for units within the same lot.(b)(4).
 
Event Description
The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens, -4.0 diopter into the patient's left (os) eye.Intraoperatively the lens was exchanged due to a "slight scratch" being found on the lens near the optical part.The problem was resolved.This occurred on (b)(6) 2020.The cause of the event is reported as unknown.
 
Manufacturer Narrative
Additional information: h3- device evaluation: lens was returned dry in a micro centrifuge vial with residue on the lens.Visual inspection found foreign residue and the lens has a curved shape.On 2x a small scratch was noted near the optic.Claim# (b)(4).
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Type of Device
PHAKIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia, ca
MDR Report Key10457347
MDR Text Key204542818
Report Number2023826-2020-01882
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 foreign,health professional,o
Type of Report Initial,Followup
Report Date 07/30/2020
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_13.2
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2020
Initial Date Manufacturer Received 07/30/2020
Initial Date FDA Received08/26/2020
Supplement Dates Manufacturer Received10/22/2020
Supplement Dates FDA Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
Patient Age29 YR
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