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

Model Number VICM5_13.2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dry Eye(s) (1814); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/15/2023

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vicm5_13.2.-8.5 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.Monocular diplopia, discomfort, and fluctuating vision was observed.Paitient perscribed cyclogyl 1% bid.Lens remains implanted.Problem not resolved.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

A4 - unk a5 - unk a6 - unk h6 - health effect impact code 4644: cyclogyl 1% bid h6 - work order search: no similar complaint type events were reported for units within the same lot.(b)(4).

Manufacturer Narrative

B4 - date of this report: (b)(6) 2024 corrected to (b)(6) 2024 claim #(b)(4).

• 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: 18886366
• MDR Text Key: 337446147
• Report Number: 2023826-2024-00865
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542119382
• UDI-Public: 00841542119382
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VICM5_13.2
• 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: 02/27/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2023
• 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#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#LIOLI-24,LOT#UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male