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

Model Number VICMO12.6

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

Patient Problems Cataract (1766); Hemorrhage/Bleeding (1888); Hyphema (1911); No Code Available (3191)

Event Date 09/02/2018

Event Type  Injury  

Manufacturer Narrative

The product is manufactured in the us, but not marketed in the us.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens, diopter -9.0 into the patient's left eye (os) on (b)(6) 2018.On (b)(6) 2018 the lens was explanted due to lens opacity (asc).Reportedly, during the initial procedure, hemorrhage of an iris vessel occured.To manage the iris bleed the surgeon introduced bubbles into the eye.Reportedly, the bublles were still present 3 days later and the icl was in contact with the anterior capsule.The surgeon states the cause of the icl touching the anterior capsule was due to the bubbles, not the icl device.The cause of the iris hemorrhage and lens opacity (asc) is reported as unknown.The problem was resolved with the lens explant.

Manufacturer Narrative

Additional information: device evaluated by mfr - device evaluation: the lens was returned in a micro centrifuge vial with moisture on lens.There was clear surgical residue on product.Visual inspection found no visible damage to lens and residue on lens.Corrected data: event - "hemorrhage of an iris vessel occurred" should be corrected to "hemorrhage of an iris vessel occured leading to hyphema" claim #(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
• MDR Report Key: 8090066
• MDR Text Key: 127907892
• Report Number: 2023826-2018-01697
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

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: 04/30/2021
• Device Model Number: VICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR