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

Model Number VTICMO13.2

Device Problems Off-Label Use (1494); Optical Problem (3001)

Patient Problems Cataract (1766); Intraocular Pressure Increased (1937); Nausea (1970); Pupillary Block (2026); Blurred Vision (2137); Vomiting (2144); Halo (2227); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This product is not marketed in the us.

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticmo13.2 implantable collamer lens, -17.50/1.50/080 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6)2020.On (b)(6) 2020 the surgeon assessed an elevated iop of 22mmhg.This was controlled within the first 24 hours with medication.Also reported is pigment dispersion, unreactive (fixed) pupil, dilated pupil, glare/haloes, iris atrophy, pupil block, and anterior subcapsular opacities.The patient also experienced naseau and excessive movement due to vomiting caused by the anesthesia.Reportedly, the lens remains implanted.The pupillary dilation was "slowly corrected within the first month, leaving an anisocoria of approx.2.5mm and presenting sectoral atrophy of the iris." the patient also reports "decrease in the intensity of the colors." the patient still experiences glaukomflecken, iris pigment dispersion, and glares at night, but is overall "really satisfied." the cause of the event is reported as "remnant of ovd behind the icl.".

• 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 ; 8002927902
• MDR Report Key: 10538715
• MDR Text Key: 207306543
• Report Number: 2023826-2020-02049
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 08/18/2020

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: 05/31/2023
• Device Model Number: VTICMO13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2020
• 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: 19 YR