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

Model Number VICMO12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyphema (1911); No Code Available (3191)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

Product manufactured but not sold in the u.S.(b)(4).Device not returned to manufacturer.

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens, -05.50 diopter, into the patient's right eye (od) on (b)(6) 2016.On (b)(6) 2016, the patient experienced hyphema.The lens was explanted on (b)(6) 2016.As of the date of mdr submission, the lens has not been returned, therefore no evaluation has been performed.

Manufacturer Narrative

Patient dob-unk is incorrect, patient's date of birth was noted on complaint questionaire.Product returned.Device evaluation: product evaluation found the lens returned dry in the lens container, but there was clear surgical residue/debris on product.Visual inspection found no visible damage to lens.(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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6258251
• MDR Text Key: 64995833
• Report Number: 2023826-2017-00083
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/20/2016

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: 08/31/2018
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR