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

Model Number VTICMO 12.1

Device Problems Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2022

Event Type  Injury  

Event Description

The reporter indicated that a 12.1mm vticmo 12.1 implantable collamer lens of -16.50/3.5/113 (sphere/cylinder/axis) was implanted into the patients right eye (od) on an unknown date.On (b)(6) 2022 the lens was exchanged for a longer length lens due to slight change of lens rx.

Manufacturer Narrative

(b)(4).Claim#: (b)(4).

Manufacturer Narrative

Additional information: b5: the reporter indicated that a 12.1mm vticmo 12.1 implantable collamer lens of -16.50/3.5/113 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6)2022.On (b)(6) 2022, the lens was exchanged for a longer length lens due to low vault.The replacement lens resolved the problem.Cause reported as user error.Device did not fail to perform as intended.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15795263
• MDR Text Key: 303631049
• Report Number: 2023826-2022-04001
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2022

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: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: VTICMO 12.1
• 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: 10/16/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 11/20/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2021
• 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
• Treatment: INJECTOR MODEL: MSI-PF, LOT# UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male