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

Model Number VTICM5_13.2

Device Problem Optical Problem (3001)

Patient Problem Visual Disturbances (2140)

Event Date 01/12/2024

Event Type  malfunction  

Event Description

The reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens -12.00/+1.5/088 (sphere/cylinder/axis) into the patient`s left eye (os) on (b)(6) 2024.The patient complained of glare and light sensitivity driving in the dark.The lens remained implanted.The cause of the event was unknown.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

A4: unk.A5: unk.A6: unk.D6b: unk.H6: work order search: no similar complaint was reported for units within the same lot.Claim #: 433744.

• 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 ; 6263037902
• MDR Report Key: 18838993
• MDR Text Key: 337570858
• Report Number: 2023826-2024-00847
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542116862
• UDI-Public: 00841542116862
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2024

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 Expiration Date: 03/31/2024
• Device Model Number: VTICM5_13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2022
• 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
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Race: Asian