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

Model Number VTICMO13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2024

Event Type  Injury  

Event Description

The reporter indicated that a 13.2mm vticmo13.2 implantable collamer lens of -10.0/4.5/180 (sphere/cylinder/axis), was implanted into the patient's right eye (od) on (b)(6) 2024.On (b)(6) 2024, the lens was exchanged for same length with a different axis due to excessive vault and the problem was resolved.Cause of the event is unknown.

Manufacturer Narrative

A4-a6:unk.H6: work order search is required: no similar complaints within associated lots were found.Claim# (b)(4).

Manufacturer Narrative

B5: 13.2mm vticmo13.2 with a -5.5/1.0/069 (sphere/cylinder/axis).Replacement lens was implanted vertically.H6: work order search was performed, but was not required.Claim# (b)(4).

Manufacturer Narrative

Device evaluation: h6: the lens was returned with liquid inside a microcentrifuge vial.Visual inspection found a haptic torn lens.Dimensional inspection found the lens to be within specifications.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 ; 800 royal oaks dr. suite:210; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 18861488
• MDR Text Key: 337182097
• Report Number: 2023826-2024-01076
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2024

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: VTICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/18/2024; 05/13/2024
• Supplement Dates FDA Received: 03/18/2024; 05/21/2024
• Date Device Manufactured: 02/19/2023
• 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: 31 YR
• Patient Sex: Female