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

Model Number MICL13.2

Device Problem Particulates (1451)

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

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

Work order search: no similar complaint type events were reported for units within the same lot.Claim #(b)(4).

Event Description

The reporter indicated that the doctor observed a particulate on a 13.2mm, micl13.2, -9.5 diopter, implantable collamer lens and chose to use the backup and the problem resolved.The reporter stated "material stuk to lens after removing from packaging, tried to clean off.Was unable to".In the reporters opinion the cause of this event is the device.There was no patient contact.

Manufacturer Narrative

H3- device evaluation: lens was returned in liquid, in lens vial.Visual inspection found no visible damage to the lens.No particulate was noted stuck on the lens.H6- device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order (s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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: 12029476
• MDR Text Key: 258654631
• Report Number: 2023826-2021-02012
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103282
• UDI-Public: 00841542103282
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2021
• 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: UNK.
• Patient Age: 27 YR
• Patient Sex: Female