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

Model Number VTICMO12.6

Device Problems Shelf Life Exceeded (1567); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

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

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

Patient information: unk.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 vticmo12.6, -4.50/+1.5/055 (sphere/cylinder/axis) implantable collamer lens, into the patient's left eye (os) on (b)(6)2017.The lens was repositioned on (b)(6) 2017.On (b)(6) 2017 the lens was exchanged with a longer lens, the surgeon noting low vault, lens rotation, and loss of bcva.The problem was resolved.

Manufacturer Narrative

Device evaluation: product evaluation found lens returned in a micro centrifuge vial with moisture and clear surgical residue/debris on product.Visual inspection found a piece of the haptic missing and clear residue on lens.(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: 7201647
• MDR Text Key: 97597264
• Report Number: 2023826-2018-00091
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: LE
• 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,Followup
• Report Date: 12/21/2017

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: 01/31/2017
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2014
• 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