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

Model Number VICM5 12.6

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 03/25/2022

Event Type  malfunction  

Event Description

The reporter indicated that a 12.6mm vicm5 12.6 implantable collamer lens of -10.00 diopter was damaged during injection/ delivery into the patients left eye (os).On (b)(6) 2022 the lens was implanted; removed intra-operatively.On the same day different surgery a replacement lens of the same mode/size and diopter was implanted and the problem was resolved.Cause reported as unknown.

Manufacturer Narrative

Pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Manufacturer Narrative

Type of investigation code: 3331- device history record (dhr) review: the dhr review indicates that the product has not been manufactured within the established process parameters and that there is indication that the manufacturing and/or processing of the device contributed to the complaint issue.Probable cause may be associated with the storage conditions of the raw materials.An action plan, capa (b)(4), has been initiated to assess and implement corrective and preventative actions for the failure identified in this complaint.Corrective and/or preventive actions are being addressed through capa-(b)(4) and this issue will continue to be tracked and trended as part of the normal device safety committee meetings and capa monitoring.Capa (b)(4) and this issue will continue to be tracked and trended as part of the normal device safety committee meetings and capa monitoring.Date of birth: (b)(6) 1995 should be removed and (b)(6) 1995 should be added.Date of implant: (b)(6) 2022 should be removed.Date of explant: (b)(6) 2022 should be removed.Medical device problem: "2017" should be added.The reporter indicated that the surgeon noted a 12.6mm vicm5_12.6 implantable collamer lens of diopter -10.0 got stuck in the cartridge/injector system and then was damaged during injection/delivery on (b)(6) 2023.There was patient contact but no patient injury.The lens was not implanted.On the same day separate surgery a replacement lens of the same model and length lens was implanted into the left eye (os) and this resolved the problem.The cause of the event was user error and the device did not fail to perform as intended.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: 14293610
• MDR Text Key: 290936831
• Report Number: 2023826-2022-01425
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/05/2022

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: 03/31/2024
• Device Model Number: VICM5 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 02/26/2024
• Date Device Manufactured: 04/29/2021
• 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#-1556477; FOAM TIP PLUNGER MODEL-FTP, LOT#-1560705; INJECTOR MODEL-MSI-PF, LOT#-1557996
• Patient Age: 27 YR
• Patient Sex: Female