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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS

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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS Back to Search Results
Model Number VTICMO12.6
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Endophthalmitis (1835); Headache (1880); Hypopyon (1913); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/12/2024
Event Type  Injury  
Manufacturer Narrative
The device remains implanted; therefore, a product evaluation cannot be performed.A review of the device labeling was completed.Hypopyon and endophthalmitis are identified in the labeling as known adverse events from icl implantation and are established risks associated with use of the device.The directions for use adequately provides instructions for icl implantation, which includes precautions, warnings and associated risks and adverse events.Dfu statements include: there may be a need for other types of secondary surgical intervention to treat some adverse events.There may be a loss of best spectacle corrected visual acuity.As with implantation of other types of intraocular lenses, potential adverse events can include, but are not limited to infection (endophthalmitis) and hypopyon.An adverse event appears to have occurred but does not appear to have been a problem with the device.Health impact- clinical code: 4581 - fibrin, reduced visual acuity.Health impact - additional surgery: (b)(6).Health effect impact code - additional medications: (b)(6) work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
 
Event Description
The reporter indicated the surgeon implanted a 12.6mm vticmo implantable collamer lens, -16.50/+1.50/061 (sphere/cylinder/axis), into the patient's left eye (os) on (b)(6) 2024.The surgeon reported presentation of hypopyon suspecting endophthalmitis.The patient experienced blurred vision and headaches.On day two post-op, the patient presented with fibrin and reduced visual acuity.Management included antibiotic injection, increased steroid drop therapy and ac washout.Gram stain and cultures were negative for organisms.On 31-jan-2024, patient visual acuity is reported as 20/25.The surgeon suspects cause of the event may be associated with the patient's recent sinus infection.The lens remains implanted.
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Type of Device
PHAKIC TORIC 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
6263037902
MDR Report Key18669620
MDR Text Key334913752
Report Number2023826-2024-00272
Device Sequence Number1
Product Code QCB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/13/2024
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? No
Device Operator Health Professional
Device Model NumberVTICMO12.6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/13/2024
Initial Date FDA Received02/08/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/20/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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