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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 13.7
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Edema (1791); Intraocular Pressure Increased (1937)
Event Date 03/15/2023
Event Type  Injury  
Manufacturer Narrative
H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim #: (b)(4).
 
Event Description
The reporter indicated that a 13.7mm, vicmo 13.7, -14.50 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2023.On (b)(6) 2023 the lens was explanted due to elevated intraocular pressure without pupil block and angle closure.A replacement lens of shorter length was later implanted and the problem resolved.It was also reported that corneal edema was noticed on (b)(6) 2023, however it did not require treatment beyond was is standard after ocular surgery and the corneal edema resolved.In the reporters opinion the cause of the event was the device.
 
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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 SUGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer Contact
joselene enriquez
1911 walker avenue
monrovia, CA 91016
MDR Report Key16850587
MDR Text Key314355541
Report Number2023826-2023-01613
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P030016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/04/2023
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 Model NumberVICMO 13.7
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/04/2023
Initial Date FDA Received05/01/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2022
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
INJECTOR MODEL: MSI-TF, LOT# 1589898.
Patient Outcome(s) Required Intervention;
Patient Age29 YR
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