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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 VICMO 13.2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blurred Vision (2137)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The reporter indicated that the surgeon implanted a 13.2mm vicmo13.2, -7.50 diopter, implantable collamer lens into the patient's right eye (od) in 2015.Refractive change overtime was observed.Lens remains implanted.Cause of the event is reported as unknown.Additional information has been requested but none has been forthcoming.
 
Manufacturer Narrative
Additional information: addtional information proivded through out form.Claim# (b)(4).
 
Event Description
The reporter indicated that the surgeon implanted a 13.2mm vicmo13.2, -7.50 diopter, implantable collamer lens into the patient's right eye (od) in 2015.On (b)(6) 2024 lens exchanged with a same length different diopter lens due to refractive change overtime.This resolved the problem.Cause of the event is reported as unknown.Reportedly, all good and patient is happy.
 
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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
Manufacturer (Section G)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer Contact
joselene muniz
1911 walker avenue
monrovia, CA 91016
MDR Report Key19119695
MDR Text Key340308184
Report Number2023826-2024-01619
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/25/2024
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? Yes
Device Operator Health Professional
Device Expiration Date02/28/2018
Device Model NumberVICMO 13.2
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/25/2024
Initial Date FDA Received04/16/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/31/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/18/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CARTRIDGE MODEL#SFC-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-PF,LOT#UNK
Patient Outcome(s) Required Intervention;
Patient SexFemale
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