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

Model Number VICM5_13.2

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 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The reporter indicated that a 13.2mm vicm5_13.2 implantable collamer lens, -8.5 diopter tore during injection into the patient's right (od) eye.This occurred on (b)(6) 2021.There was patient contact with the lens but the lens was not implanted.No patient injury reported.An alternate lens was implanted and the problem is resolved.The cause of the event is reported as user error: "the haptic was hooked on the injector and the lens broke.".

Manufacturer Narrative

B5: additional information: reportedly, the device failed to perform as expected.The lens was caught in the injector; h6: investigation code 4110: lens work order search.One similar complaint type event reported for units within the same lot.Claim# (b)(4).

Manufacturer Narrative

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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 12222276
• MDR Text Key: 263598585
• Report Number: 2023826-2021-02860
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2021

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: 12/31/2023
• Device Model Number: VICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 08/09/2021; 11/01/2021
• Supplement Dates FDA Received: 09/03/2021; 11/06/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2021
• 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#-1482134; FOAM TIP PLUNGER MODEL-FTP, LOT#-1495111; INJECTOR MODEL-MSI-TF, LOT#-UNK
• Patient Age: 30 YR
• Patient Sex: Female