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U.S. Department of Health and Human Services

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

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STAAR SURGICAL COMPANY ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS Back to Search Results
Model Number VTICMO13.2
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Intraocular Pressure Increased (1937); Pain (1994); Vomiting (2144); No Code Available (3191)
Event Date 02/23/2015
Event Type  Injury  
Event Description
The reporter indicated the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens in the patient's right eye (od) on (b)(6) 2015.The lens was explanted on (b)(6) 2015 due to excessive vaulting, significant reduction of irido-corneal angles, angle closure with elevated intraocular pressure and an unreactive pupil (fixed).The patient experienced severe headache, vomiting and pain.
 
Manufacturer Narrative
This product is manufactured in the u.S.But not marketed in the u.S.Pt weight: unk.(b)(4).Device evaluated by manufacturer? no.Lens not returned.Method: work order search.Result: a lens work order search was performed and no similar complaints were found within the work order.Conclusions: (no conclusion can be drawn): based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).Lens not returned.
 
Manufacturer Narrative
Visual inspection of the returned product found one haptic torn.The lens was returned in liquid.The lens was rehydrated in bss for re-measurement.The lens length was measured and the result of the measurement was compared against the original value and the lens was found to be in specification.Medical review - according to use fmea (failure modes and effect analysis) it has been determined that excessive vaulting is a consequence of a wrong lens use failure mode (i.E.Improper white to white measurement, variability of the white to white measurements based upon different techniques utilized, improper sulcus to sulcus measurement (if ubm used), and patient condition; poor correlation of white to white measurement and length of ciliary sulcus in an individual case; irregular ciliary sulcus or ciliary sulcus cyst).Several conditions may arise from this event (i.E.Pupillary block, malignant glaucoma, increased iop etc.).To prevent any of these complications from occurring, staar recommends that the lens be explanted and/or exchanged with the right size once the surgeon determines that this condition may affect the outcome of the patient's vision.Angle closure/elevated iop in the presence of a vicmo/vticmo model may occur due to: remaining viscoelastic in the posterior chamber, oversized icl with angle closure, too narrow angles/crowded ac due to small eye anatomy preoperatively, unexpected abnormal anatomy or tissue abnormalities (presence of iris/ciliary body cysts), blockage of the port by remaining viscoelastic, or by an inflammatory membrane, etc.Based on the complaint history, work order search, medical review and the evaluation of the returned product, a probable root cause of excessive vaulting has been determined to be related to the inaccuracy of the white to white measurement or a mismatch between white to white and the sulcus to sulcus diameter.(b)(4).
 
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Brand Name
ICL (IMPLANTABLE COLLAMER LENS)
Type of Device
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
althea watson
1911 walker avenue
monrovia, CA 91016
6263037902
MDR Report Key4721367
MDR Text Key5661763
Report Number2023826-2015-00429
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Distributor,distributor,forei
Reporter Occupation Other
Type of Report Initial
Report Date 03/24/2015
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 Physician
Device Expiration Date12/31/2017
Device Model NumberVTICMO13.2
Other Device ID NumberDIOPTER -11.0/+2.0/X095
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/24/2015
Initial Date FDA Received04/22/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2015
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 AND LOT NUMBER UNK
Patient Outcome(s) Required Intervention;
Patient Age22 YR
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