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

Model Number VICMO12.1

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

Weight, ethnicity, race - unk.Pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Claim# (b)(4).

Event Description

The reporter indicated that a black foreign object was found in a vial of a 12.1mm vicmo12.1 implantable collamer lens diopter -18.0.This occurred on (b)(6) 2021.Reportedly, the surgery was not performed because a linear foreign body was found in the vial before it was removed from the vial.An alternate lens was successfully implanted at a later date and the problem is resolved.The doctor terminated the operation without affecting the patient's eyes.

Manufacturer Narrative

H3: device history report: based on the results of the investigation, the dark fiber was identified, to be consistent with rayon with a blue, organic dye, commonly found in all clothing types.Due to the wide use of rayon in clothing, a definitive root cause is unable to be determined.Operators involved in the manufacturing of the nonconforming lens have been retrained.And made aware of the importance of verifying, that no foreign objects are present within the lens vial.Claim# (b)(4).

Manufacturer Narrative

H3: lens was returned in liquid in a vial.Foreign material was noted, floating in vial.And was not opened, during visual inspection.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: 12558546
• MDR Text Key: 274499117
• Report Number: 2023826-2021-03811
• 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: 09/09/2021

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: VICMO12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 12/28/2021; 01/24/2022
• Supplement Dates FDA Received: 01/20/2022; 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2021
• 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: 32 YR
• Patient Sex: Female