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

Model Number VTICH12.6

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Blurred Vision (2137); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This product is manufactured but not marketed in the u.S.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vtich12.6, +2.5/+3.0/030 (sphere/cylinder/axis) implantable collamer lens, into the patient's left eye (os) on (b)(6)2018.The surgeon reports refractive surprise.Reportedly, the lens remains implanted.

Manufacturer Narrative

The implantable collamer lens (vtich12.6) was removed and exchanged on (b)(6) 2018.The exchanged resolved the problem.(b)(4).

Manufacturer Narrative

The surgeon implanted a 12.6mm vtich12.6 +4.50/+3.5/031 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os).(b)(4).

Manufacturer Narrative

Additional data: device evaluation: lens was returned dry, in lens case/vial.There was clear residue/debris on product.Visual inspection found the haptic broken.Dimensional and functional inspection found that lens was within specification.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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 ; 6263037902
• MDR Report Key: 7639948
• MDR Text Key: 112436290
• Report Number: 2023826-2018-00956
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/31/2018

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?: Yes
• Device Operator: Physician
• Device Model Number: VTICH12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 08/13/2018; 09/04/2018; 09/04/2018
• Supplement Dates FDA Received: 08/21/2018; 09/04/2018; 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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