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 Headache (1880); Intraocular Pressure Increased (1937); Pain (1994); Blurred Vision (2137); Visual Disturbances (2140); Vitreous Detachment (2445)

Event Date 12/10/2012

Event Type  Injury  

Manufacturer Narrative

This product is manufactured but not marketed in the u.S.Work order search: no similar complaint types reported for units within the same lot.(b)(4).Device remains implanted.

Event Description

The reporter indicated that the surgeon implanted a 11.5mm ticm115v4, implantable collamer lens, into the patient's left eye (os) on (b)(6) 2012.Beginning on (b)(6) 2012 the patient began to experience blurred vision.Patient also experiences flashes due to posterior vitreous detachment (pvd).Additional symptoms include pain, observance of multiple images, severe headache, inability to focus on objects or words, poor, vision, elevated iop due to steroied rsponse, and lens rotation.On (b)(6) 2013 the paitent was put on antiglaucoma therapy as he is a "steroid responder." the lens has not been returned for evaluation.Reference mdr 2023826-2017-00903 for fellow eye.

• 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: 6606309
• MDR Text Key: 76479898
• Report Number: 2023826-2017-00914
• 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: distributor,foreign,health pr
• 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: 06/30/2015
• 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: 07/20/2012
• 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): Other
• Patient Age: 23 YR