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

Model Number VICM5_13.2

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

This product is not marketed in the us.Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2 mm vicm5_13.2, -7.0 diopter, implantable collamer lens in the patient's left eye (os) on (b)(6) 2018.Upon unfolding of the lens, deposits and glittering/oily residue was seen on the optic.It was flushed with bss, but only some of the residue came off and the lens remained partially covered.The lens was intraoperatively exchanged with another lens.Upon post-op examination, the residue is still visble on the peripheral optic, but not visually significant for the patient.

Manufacturer Narrative

The patient still has the traces on the lens inside the eye but no visual impacts and no inflammation.The lens was returned in liquid, in a vial.Visual inspection found no visible damage to the lens.No oily/glittering residue noted on the lens.The delivery system was returned loose in lens box.Visual inspection found no visible damage to the lens and foreign material on/in device (residue on device).Type of reportable event in initial mdr should be malfunction.(b)(4).

Manufacturer Narrative

Device evaluation: no oily / glittering residue on the product.Corrected data: device evaluation: the delivery system was returned loose in a lens box.There was residue on product.Visual inspection found no visible damage to the device and foreign material on / in device (residue on device).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: 7456989
• MDR Text Key: 106381741
• Report Number: 2023826-2018-00597
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• 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,Followup
• Report Date: 03/27/2018

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: Physician
• Device Expiration Date: 03/31/2020
• Device Model Number: VICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/24/2018
• Supplement Dates Manufacturer Received: 04/23/2018; 06/28/2018
• Supplement Dates FDA Received: 05/17/2018; 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• 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: 39 YR