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

Model Number VICM5 13.2

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Intraocular Pressure Increased (1937); Red Eye(s) (2038)

Event Date 03/14/2022

Event Type  Injury  

Event Description

The reporter indicated that a 13.2mm vicm5 13.2 implantable collamer lens of -8.0 diopter was implanted into the patients right eye (od) on (b)(6) 2022.On (b)(6) 2022 the lens was explanted due to inflammation and pigment dispersion occurred.; then steroid eye drops were prescribed and induced iop.A trabeculectomy was performed.Cause is due to a patient related factor of pigment dispersion syndrome.

Manufacturer Narrative

Weight, ethnicity, and race: unk.(b)(4).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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14710489
• MDR Text Key: 294149435
• Report Number: 2023826-2022-01917
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2022

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 13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/16/2022
• Date Device Manufactured: 02/26/2022
• 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
• Treatment: CARTRIDGE MODEL: SFC-45: LOT# UNK; FOAM TIP PLUNGER (FTP), LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male