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

Model Number VICM5_12.6

Device Problem Unintended Movement (3026)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

A4: unk.A5: unk.A6: unk.H6: work order search: no similar complaint type events were reported for units within the same lot.Claim#: (b)(4).

Event Description

The reporter indicated that the surgeon implanted upside down a 12.6mm vicm5_12.6, -8.5 diopter, implantable collamer lens, into the patient's left eye(os) on (b)(6) 2024.There was patient contact (lens touched the eye) with no patient injury.The lens was removed on (b)(6) 2024 with a same size, similar (sphere/cylinder/axis) lens.The problem was resolved.The lens was implanted, removed, and replaced intraoperatively.Cause of the event is reported as unknown.Reportedly, patient very happy with vision.

• 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: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18738711
• MDR Text Key: 336464698
• Report Number: 2023826-2024-00703
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2023
• 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
• Treatment: CARTRIDGE MODEL#SFC-45,LOT#1660106; FOAMTIPPLUNGER MODEL#FTP,LOT#1710776; INJECTOR MODEL#MSI-PF,LOT#1390762
• Patient Age: 30 YR
• Patient Sex: Female