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

Model Number VTICM5_13.2

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

Patient Problem Blurred Vision (2137)

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -9.50/+6.0/025 (sphere/cylinder/axis), in the patients left eye (os) on (b)(6) 2019.The lens was reported as having excessive vaulting and the patient experienced a refractive surprise.The lens remains implanted.The cause of the event was unknown.

• 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 ; 6263037902
• MDR Report Key: 9536347
• MDR Text Key: 190801678
• Report Number: 2023826-2019-02508
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: VTICM5_13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2018
• 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