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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
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Product code: unk; esubmitter software does not allow for unk entry.This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).
 
Event Description
The reporter indicated that the surgeon implanted an implantable collamer lens into the patient's eye.The surgeon states there is a high vault.Reportedly, the lens remains implanted.Attempts to obtain additional information have not been successful.
 
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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
Manufacturer (Section G)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia, ca
Manufacturer Contact
cynthia thai
1911 walker avenue
monrovia, ca 
3037902237
MDR Report Key10457339
MDR Text Key204545906
Report Number2023826-2020-01883
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/30/2020
Initial Date FDA Received08/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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