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

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).

• 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 Key: 4721367
• MDR Text Key: 5661763
• Report Number: 2023826-2015-00429
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• 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 Date: 12/31/2017
• Device Model Number: VTICMO13.2
• Other Device ID Number: DIOPTER -11.0/+2.0/X095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL AND LOT NUMBER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR