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

Model Number VICMO13.7

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.7mm vicmo13.7; -10.5 diopter implantable collamer lens into the patient's left eye (os) on (b)(6) 2022.The patient experienced excessive vaulting.On (b)(6) 2022 the lens was explanted and this resolved the problem.The cause of the event was reported as a patient related factor and noted the device failed to perform as intended and indicated "the patient had smaller ciliary processes; so the doctor tried to replace the lens model from 13.2 to 13.7 but still low vault about 40um and the patient decided to give up the operation".

• 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: 15080945
• MDR Text Key: 296368584
• Report Number: 2023826-2022-02373
• 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
• Report Date: 07/15/2022

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: VICMO13.7
• 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: 07/15/2022
• Initial Date FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2021
• 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: INJECTOR MODEL-MSI-PF, LOT#-1449235
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female