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

Model Number VICMO13.2

Device Problems Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.Patient code (b)(4): no code available (secondary surgery, lens exchange).Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that, while implanting a 13.2mm vicmo13.2 implantable collamer lens, diopter -11.5 into the patient's left eye (os), the lens broke.The lens was implanted on (b)(6) 2018.Reportedly, on (b)(6) 2018 the lens was exchanged with an alternate lens and the problem is resolved.Also reported-a white foreign body adhered to the back surface of the lens.Attempts to obtain additional information have not been successful.

Manufacturer Narrative

The lens was returned in a micro centrifuge vial with moisture on lens.There was residue/debris on product.Visual inspection found the haptic torn, foreign material on lens surface (residue on lens), and there was red residue/debris on lens.Corrected data: date received by manufacturer - 16 may 2018 is incorrect in initial mdr, should be 15 may 2018.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• 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: 7594271
• MDR Text Key: 110843317
• Report Number: 2023826-2018-00829
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2020
• Device Model Number: VICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 07/23/2018
• Supplement Dates FDA Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 26 YR