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

Model Number VICMO12.6

Device Problem Misfocusing (1401)

Patient Problems Fatigue (1849); Blurred Vision (2137)

Event Date 04/22/2022

Event Type  Injury  

Manufacturer Narrative

Claim#: (b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicmo12.6; -4.0 diopter implantable collamer lens into the patient's left eye (os) on (b)(6) 2022.The surgeon reports refractive surprise, blurred vision and visual fatigue.It notes "patient presbyopia +1.25".On (b)(6) 2022 the lens was exchanged with a same length but different power lens and this resolved the problem.The cause of the event was reported as unknown.

Manufacturer Narrative

H3: device evaluation: the lens was returned with residue/debris in a microcentrifuge vial.Visual inspection found no visible damage to the lens.Dimensional and functional inspection found the lens to be within specifications.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: 14983342
• MDR Text Key: 295680565
• Report Number: 2023826-2022-02208
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030016
• 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
• Report Date: 07/07/2022

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: VICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/11/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2021
• 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): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female