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

Model Number VTICM5_12.6

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

This product is manufactured but not marketed in the u.S.(b)(4).

Event Description

The reporter stated that the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -6.0/+1.5/095 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2018.On (b)(6) 2018, the lens was exchanged with a different lens due to the surgeon implanting the incorrect lens into the eye.The surgeon mixed up the lenses for the os and od eyes.The problem was resolved.Reference mfr report# 2023826-2018-00283 (claim# (b)(4)) for previous part of this case.

Manufacturer Narrative

Device evaluation: product evaluation found the lens returned dry in a micro centrifuge vial with clear surgical residue/debris on lens.Visual inspection found no visible damage and residue on lens.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker ave.; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker ave; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 7356134
• MDR Text Key: 102995325
• Report Number: 2023826-2018-00436
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 02/23/2018

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: 10/31/2020
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2017
• 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: 23 YR