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

Model Number VICM5_12.1

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Headache (1880); Inflammation (1932); Intraocular Pressure Increased (1937); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/12/2022

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.1mm vicm5_12.1 implantable collamer lens, -08.00 diopter, in the patients left eye (os), on (b)(6) 2021.The patient experienced elevated intraocular pressure (iop) and ac inflammation cells.The lens remained implanted.The cause of the event was unknown.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

Corrected data: b5- corrected to "the reporter indicated the surgeon implanted a 12.1mm vicm5_12.1 implnatable collamer lens, -08.00 diopter, in the patient's left eye (os), on (b)(6) 2021.The patient experienced elevated intraocular pressure (iop), ac inflammation cells, pain, headaches, nausea, numbness of leg, generalized body weakness, inflammation, pigment cells, medication was prescribed.The lens remains implanted.The cause of the event is unknown." claim# (b)(4).

Manufacturer Narrative

Corrected data: h6- health impact: clinical code: 4581- nausea; numbness of leg.Should have been included in supplemental #1 med watch report.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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 14046187
• MDR Text Key: 288822794
• Report Number: 2023826-2022-01093
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: NA
• 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: 03/16/2022

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: VICM5_12.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 07/05/2022; 07/06/2022
• Supplement Dates FDA Received: 07/05/2022; 07/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2021
• 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.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL MSI-PF - LOT # UNK.
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Sex: Female