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

Model Number VTICM5_13.2

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

Patient Problems Blurred Vision (2137); No Known Impact Or Consequence To Patient (2692); No Code Available (3191); Missing Value Reason (3192)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

This product is not mark.Eted in the us.No similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a vticm5_13.2, -9.5/+1.0/003 (sphere/cylinder/axis), implantable collamer lens into the patients left eye (os) on (b)(6) 2018.Low vault was observed, lens remains implanted.It was reported that the cause of event was a patient related factor.Surgeon plans to exchange the lens in (b)(6); if additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Corrected data: adverse event should be marked in previous mdr.Required intervention should be marked in previous mdr.Refractive surprise was also reported.The lens was exchanged for a longer length, stronger power lens.Should be added to the initial mdr.Date received by mfr: should be corrected to "october 14,2019" in the previous mdr.(b)(4).

Manufacturer Narrative

Corrected data: "lens remains implanted" should be corrected to "lens was exchanged on (b)(6) 2019 for a longer length lens.The problem was resolved." in the initial mdr."the cause of the event was a patient related factor"should be corrected to " the cause of the event was user error." in the initial mdr.Additional information: secondary surgical intervention - exchange.(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
• MDR Report Key: 8219629
• MDR Text Key: 132210480
• Report Number: 2023826-2019-00045
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 12/06/2018

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: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: VTICM5_13.2
• 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: 12/06/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 10/15/2019; 01/17/2020
• Supplement Dates FDA Received: 10/16/2019; 01/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR