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

Model Number VTICMO13.7

Device Problems Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)

Patient Problems Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).No similar complaint type events reported for units within the same lot.(b)(4).Resubmission of initial mdr requested by fda.

Event Description

The reporter indicated the surgeon implanted a 13.7mm vticmo13.7, -11.0/+3.5/174 (sphere/cylinder/axis) implantable collamer lens in the patient's right eye (od) on (b)(6) 2014.The lens has an excessive vault.The patient experienced loss of best-corrected visual acuity, significant reduction of the irido-corneal angles (ica), unreactive pupil (fixed), angle closure with elevated intraocular pressure, glare/halos, blurred vision and iris atrophy.Reportedly, the lens remains implanted.

Manufacturer Narrative

Additional information: the lens was explanted at an unknown date.Explanted date unknown.Device evaluation: the lens was returned dry in a lens case/vial with clear surgical residue/debris on product.A visual inspection was performed and observed no visible damage to the lens.(b)(4).Claim #: (b)(4).

• 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6262927902
• MDR Report Key: 6393935
• MDR Text Key: 173450878
• Report Number: 2023826-2015-00168
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2015

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: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: VTICMO13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2015
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: 02/28/2017
• Supplement Dates FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2014
• 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
• Patient Outcome(s): Other; Required Intervention