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

Model Number VTICM5_13.2

Device Problem Misfocusing (1401)

Patient Problems Corneal Edema (1791); Blurred Vision (2137)

Event Date 11/15/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2; -10.50/2.0/167 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.The surgeon reports there was a refractive error due to negative sign not entered into cylinder part of refraction in ocos.Lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Additional information: b5 - it was later reported that on (b)(6) 2024 the lens was exchanged with a same length but different power lens and this resolved the problem.The surgeon notes "minimal edema at incision".Claim#: (b)(4).

• 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18295971
• MDR Text Key: 330463155
• Report Number: 2023826-2023-05524
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

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 Model Number: VTICM5_13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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: 21 YR
• Patient Sex: Male