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

Model Number VICMO12.1

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

Product was manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

On (b)(6) 2016, the reporter indicated that a foreign body adhesion (black dot) was observed on a 12.1mm vicmo12.1 implantable collamer lens, -5.5 diopter, prior to loading and hence had no patient contact.Another lens was used for implantation on the same day which resolved the problem.The patient's last visit was on (b)(6) 2017 with ucva 20/20.

• Brand Name: ICL (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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6327406
• MDR Text Key: 67321119
• Report Number: 2023826-2017-00121
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 01/17/2017

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: 03/31/2019
• Device Model Number: VICMO12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2016
• 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: 34 YR