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

Model Number TICM115V4

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Vitreous Floaters (1866); Headache (1880); Intraocular Pressure Increased (1937); Pain (1994); Blurred Vision (2137); No Code Available (3191)

Event Date 12/08/2012

Event Type  Injury  

Manufacturer Narrative

Patient weight: unk.This product is manufactured but not marketed in the u.S.(b)(4).Work order search: no similar complaint types reported for units within the same lot.(b)(4).Device not returned to manufacturer.

Event Description

The reporter indicated that the surgeon implanted a 11.5mm ticm115v4, implantable collamer lens, into the patient's right eye (od) on (b)(6) 2012.Beginning on (b)(6) 2012 the patient began to experience blurred vision.Patient was examined (b)(6) 2012 and vision in the right eye had deteriorated from "6/6" to "6/12." patient's vision continued to deteriorate throughout the week.After re-examination on (b)(6) 2012, it was discovered that the lens had rotated.The lens was repositioned on (b)(6) 2013.On (b)(6) 2013 the lens again rotated, blurring the patient's vision.Additional symptoms include "prolonged severe headache," flashes, "floaters," and elevated iop due to a steroid response.Patient was given a ubm test on (b)(6) 2013.On the (b)(6) 2013 the lens was exchanged for a longer lens.The lens has not been returned for evaluation.Reference mdr 2023826-2017-00903 for case resolution.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; hauptstrasse 104; nidau, 2560 ; SZ 2560
• Manufacturer (Section G): STAAR SURGICAL COMPANY; hauptstrasse 104; nidau, 2560 ; SZ 2560
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6606084
• MDR Text Key: 76457843
• Report Number: 2023826-2017-00902
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2017

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: 03/31/2015
• Device Model Number: TICM115V4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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): Required Intervention
• Patient Age: 23 YR