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

Model Number VICMO13.2

Device Problems Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.No similar complaints reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated that, while implanting a 13.2mm vicmo13.2, -9.0 diopter implantable collamer lens into the patient's left eye (os), the lens tore.The lens was implanted and removed intraoperatively on (b)(6) 2021.An alternate lens was implanted on a later date and the problem was resolved.Reportedly, there was no patient injury.The cause of the event is reported as unknown.

Manufacturer Narrative

B5-additional information: the reporter states the cause of the event is "improper operation." reportedly training has been conducted.(b)(4).

Manufacturer Narrative

B5 - "the reporter indicated that, while implanting a 13.2mm vicmo13.2, -12.5 diopter implantable collamer lens into the patient's left eye (os), the lens tore.The lens was implanted and removed intraoperatively on (b)(6) 2021.An alternate lens was implanted on a later date and the problem was resolved.Reportedly, there was no patient injury.The cause of the event is reported as unknown." claim #(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• 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 ; 8002927902
• MDR Report Key: 12840492
• MDR Text Key: 282578674
• Report Number: 2023826-2021-04370
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: VICMO13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 12/04/2021; 02/11/2022
• Supplement Dates FDA Received: 12/30/2021; 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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
• Patient Age: 30 YR
• Patient Sex: Male