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

Model Number VICM5_12.6

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

Product manufactured but not sold in the u.S.No similar complaint type events reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that as the surgeon was preparing to implant a 12.6mm vicm5_12.6 implantable collamer lens, -10.0 diopter into the patient's left eye (os), it was discovered to have a foreign body adhesion.This was discovered after the surgeon removed the lens from the vial.There was no patient contact with the lens.This occurred on (b)(6) 2019.The cause of the event is reported as device.

Manufacturer Narrative

Device evaluation: the lens was returned dry in a micro centrifuge vial.There was clear surgical residue on product.Visual inspection found no visible damage to the lens and residue on the lens.A piece of foreign body was also stuck on the lens.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: 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: 8437898
• MDR Text Key: 139419109
• Report Number: 2023826-2019-00451
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

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: 09/30/2021
• Device Model Number: VICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2018
• 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
• Patient Age: 22 YR