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

Model Number VTICMO12.6

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Markings/Labelling Problem (2911)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.One similar complaint type event was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that a vticmo 12.6 -12.00/+1.50/082, serial (b)(4), implantable collamer lens was implanted into the patients left eye (os).The reporter states that the same model, power and serial number of this lens (vticmo 12.6 -12.00/+1.50/082, serial # (b)(4) was shown on the patient chart label inside the box for another lens with vticmo 12.6 -12.00/+1.50/083, serial # (b)(4) indicated on the external box label.The lens remains implanted and it was reported that there is no negative feedback or complaints about the patient's condition.

Manufacturer Narrative

B5: the reporter stated that the serial # (b)(6) (vticmo 12.6 -12.00/+1.50/082) was shown on the patient chart label inside the box for another lens with serial# (b)(6) (vticmo 12.6 -12.00/+1.50/083) indicated on the external box label.Reportedly, "the lens was not implanted in 2018 due to patient's reasons." the vticmo 12.6 lens with a diopter of -12.00/+1.50/082 (sphere/cylinder/axis), serial (b)(6) was implanted to the patient's left eye (os) on (b)(6) 2020.The lens was exchanged on (b)(6) 2020 for a longer length lens due to low vaulting.The problem was resolved.Claim#: (b)(4).

Manufacturer Narrative

H3 device evaluation: the lens was returned in liquid in a microcentrifuge vial.Visual inspection found no visible damage to lens.Complaint descriptions package label does not match serial number on sticker.Unable to verify complaint statement due to lens not returned in original packaging.Claim #(b)(4).

Manufacturer Narrative

H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, the probable cause of the failure is likely due to failure to follow procedure by packaging more than one lens at a time and therefore inadvertently packaging the incorrect patient chart label.A second probable cause identified is due to inadequate final verification process of the patient chart label.Corrective actions for a similar discrepancy regarding the packaging of an incorrect patient chart label have been identified and have been implemented under capa m18-12.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
• MDR Report Key: 8122335
• MDR Text Key: 129156577
• Report Number: 2023826-2018-01670
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/31/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: VTICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 12/01/2018
• Supplement Dates Manufacturer Received: 05/19/2021; 02/16/2022; 03/25/2022
• Supplement Dates FDA Received: 06/03/2021; 03/15/2022; 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2018
• 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: UNK.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female