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 Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2019

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 removed a 12.6mm vicm5_12.6 implantable collamer lens, -9.5 diopter from the vial, using the microscope, he discovered a black foreign body on the lens.This occurred on (b)(6) 2019.The surgeon did not use the lens and closed the vial cap.An alternate lens was successfully implanted.

Manufacturer Narrative

The lens was returned in liquid, in the lens vial.Visual inspection found a black particle on the lens.Method code 3331, 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.Method code 4112-the particulate was isolated and tested (b)(6) 2019.Fourier transform infrared spectroscopy (ftir) results found the spectrum to be masked by the presence of one or more inorganic components which prevented a definitive definition.The best spectral matches included a variety of epoxy resins and a weaker match was made with chlorinated polyethylene.The particulate was found to be approximately 288um long and 222um wide.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8552496
• MDR Text Key: 143268358
• Report Number: 2023826-2019-00663
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

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: 11/30/2021
• Device Model Number: VICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR