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 09/23/2018

Event Type  malfunction  

Manufacturer Narrative

Product manufactured but not sold in the u.S.Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens, -10.0 diopter into the patient's right eye (od) on (b)(6) 2018.The surgeon reports foreign body adhesion which was found during implant.Intraoperatively the lens was removed and replaced and the problem was resolved.The cause of the event is listed as unknown.The surgeon states he believes the "foreign body was originally adhesive on the lens.".

Manufacturer Narrative

Device evaluation: the lens was returned dry in a micro centrifuge vial.There was clear surgical residue on product.Visual inspection found the haptic torn and residue on the lens.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: 8172147
• MDR Text Key: 130623337
• Report Number: 2023826-2018-01845
• 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: 11/23/2018

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: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: VICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR