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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 VCMO13.2
Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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
It was reported that a 13.2mm, vicmo13.2, -9.00 diopter, implantable collamer lens was implanted into the patient right eye (od) as a replacement lens due to low vault but it did not resolve the problem (vault is still not ideal).On (b)(6) 2020 the reporter stated " the patient's condition is good now except the low vault (about 200).To explain why: exchanged lens didn't resolve the problem, the doctor said maybe the eyes (both od&os) of the patient's ciliary sulcus morphology were not good which caused the low vault.In the end, the surgeon decided to follow up this case.".
 
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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 
MDR Report Key10432997
MDR Text Key204048292
Report Number2023826-2020-01801
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Physician
Type of Report Initial
Report Date 07/21/2020
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 Date09/30/2022
Device Model NumberVCMO13.2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/21/2020
Initial Date FDA Received08/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2019
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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