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

Model Number VTICM5_12.6

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/11/2023

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6, -2.0/4.0/105 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.The lens was replaced with a shorter length lens due to angle closure and excessive vault on (b)(6) 2023.This resolved the problem.Cause of the event is reported as unknown, patient related factor.

Manufacturer Narrative

A4 - unk; a5 - unk; a6 - unk; h6 - health effect clinical code 4581: angle closure.Claim# (b)(4).

Manufacturer Narrative

Corrected data: b5: the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens of diopter -2.0/+4.0/105 (sphere/cylinder/axis) into the patients right eye (od) on (b)(6) 2023.The patient experienced an excessive vault and angle closure.On (b)(6) 2023 the lens was exchange for the same model and power but shorter length lens and the problem was resolved.Reportedly "the patient's visual acuity is not yet improved at the 1 week post-op visit but the vault has improved with good results".The reporter indicated the cause of the event was a patient related factor/ unknown.H6: medical device problem code: 1494- off label use (age>45).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 muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18427342
• MDR Text Key: 331798256
• Report Number: 2023826-2024-00008
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: VTICM5_12.6
• 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: 12/15/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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: CARTRIDGE MODEL#SFC-45,LOT#UNK.; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK.; INJECTOR MODEL#MSI-PF,LOT#UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male