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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 VICMO13.2
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/18/2020
Event Type  Injury  
Manufacturer Narrative
This product is not marketed in the us.Claim # (b)(4).
 
Event Description
The reporter indicated that a 13.2mm, vicmo13.2, -9.0 diopter, implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2020.On (b)(6) 2020 the lens was exchanged for a longer length lens due to low vault.This exchange resolved the problem.
 
Manufacturer Narrative
Additional information; h3 - device evaluation: lens returned in a micro-centrifuge vial with moisture.Visual inspection found no visible damage to lens.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 91016
MDR Report Key11093456
MDR Text Key224262816
Report Number2023826-2020-03268
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
PMA/PMN Number
NA
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 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2023
Device Model NumberVICMO13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2021
Initial Date Manufacturer Received 12/02/2020
Initial Date FDA Received12/30/2020
Supplement Dates Manufacturer Received04/09/2021
Supplement Dates FDA Received05/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARTRIDGE MODEL: SFC-45 W/FTP, LOT# 1474159.; INJECTOR MODEL: MSI-PF, LOT# 1449235.; CARTRIDGE MODEL: SFC-45 W/FTP, LOT# 1474159; INJECTOR MODEL: MSI-PF, LOT# 1449235
Patient Outcome(s) Required Intervention;
Patient Age22 YR
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