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

Model Number VICMO12.6

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Intraocular Infection (1933); Visual Impairment (2138); Vitrectomy (2643); No Code Available (3191)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

The 13.2mm vicmo13.2 implantable collamer lens is incorrect, correct implantable collamer lens used was 12.6mm vicmo12.6.Model vicmo13.2 is incorrect, correct data is vicmo12.6.Claim# (b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vicmo13.2 implantable collamer lens, -8.50 diopter, into the patient's right eye (od) on (b)(6) 2017.Beginning on (b)(6) 2017 the patient began experiencing the following: low vault, bcva of "only hand motions," decreased accommodation, and difficulty in near vision.The patient underwent a vitrectomy, then was hospitalized for approximately 1 week.Patient had an infection-suspected endophthalmitis but tests came out negative.Tested positive however, for "fungal-like" organisms and gram positive cocci.Patient was treated with iv antibiotics and drops, ppv.Lens was explanted (b)(6) 2017.As of the date of mdr submission, the lens has not been returned for evaluation.

Manufacturer Narrative

The 13.2mm vicmo13.2 implantable collamer lens is incorrect, correct implantable collamer lens used was 12.6mm vicmo12.6.Model vicmo13.2 is incorrect, correct data is vicmo12.6.Claim# (b)(4).

Manufacturer Narrative

The 13.2mm vicmo13.2 implantable collamer lens is incorrect, correct implantable collamer lens used was 12.6mm vicmo12.6.Model vicmo13.2 is incorrect, correct data is vicmo12.6.Claim# (b)(4).

Manufacturer Narrative

The lens was returned dry in a lens case/vial.Visual inspection found haptic broken/bent and clear residue and fibers on lens.Dimensional inspection found lens was within specifications.(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: 6428219
• MDR Text Key: 70685786
• Report Number: 2023826-2017-00467
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup,Followup
• Report Date: 02/22/2017

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: 08/31/2019
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/23/2017
• Supplement Dates Manufacturer Received: Not provided; 07/10/2017; 08/08/2017
• Supplement Dates FDA Received: 05/19/2017; 07/11/2017; 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 29 YR