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

Model Number VTICMO12.6

Device Problems Misfocusing (1401); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Macular Edema (1822); Inflammation (1932); Blurred Vision (2137); No Code Available (3191)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6 mm vticmo12.6, implantable collamer lens in the patient's left eye (os) on (b)(6) 2018.Lens was explanted on (b)(6) 2018 due to loss of bcva (post-op bcva 20/50) and cystoid macular edema.Antibiotics and anti-inflammatories were used to address inflammation.No infection occured.It was reported that the explant resolved the problem.Patient ok after edema adsorption.No plans to implant an icl lens.

Manufacturer Narrative

Additional data: device evaluation: the lens was returned dry, in a micro-centrifuge vial.There was clear surgical residue on the product and lens surface.Visual inspection found no visible damage to the lens.Corrected data: work order search: no similar complaint type events reported for units within the same lot - is added to initial mdr.(b)(4).

Manufacturer Narrative

Corrected data: the reporter indicated that the surgeon implanted a 12.6 mm vticmo12.6, -15/+0.5/038 (sphere/cylinder/axis), implantable collamer lens in the patient's left eye (os) on (b)(6) 2017.Lens was explanted on (b)(6) 2018 due to loss of bcva (post-op bcva 20/50) and cystoid macular edema.Antibiotics and anti-inflammatories were used to address inflammation.No infection occurred.It was reported that the explant resolved the problem.Patient ok after edema adsorption.No plans to implant an icl lens.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• 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
• MDR Report Key: 7890073
• MDR Text Key: 120745216
• Report Number: 2023826-2018-01388
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 08/28/2018

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: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: VTICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 10/19/2018; 12/04/2018
• Supplement Dates FDA Received: 11/12/2018; 12/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• 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: 31 YR