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

Model Number VICMO12.1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.Conclusion code: this lens model is contraindicated for patients with an anterior chamber depth (acd) less than 3.0mm.(b)(4).

Event Description

The reporter indicated the surgeon inserted a 12.1mm vicmo12.1 implantable collamer lens, -15.00 diopter, and the lens tore/broke during injection into the eye.The reporter indicated the lens got stuck on the plunger.The lens was removed during the same surgery with no reported injury.The cornea was clear.Another same model lens was implanted on (b)(6) 2018 and the problem was resolved.

Manufacturer Narrative

Device evaluation: lens was returned dry, in a micro-centrifuge vial.There was clear surgical residue on product.Visual inspection found the haptic torn and bent; and presence of residue on the lens surface.(b)(4).

Manufacturer Narrative

Additional data: work order search: no similar complaint type events were reported for units within the same lot.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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 7647591
• MDR Text Key: 112710247
• Report Number: 2023826-2018-00985
• 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
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2020
• Device Model Number: VICMO12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 09/25/2018; 09/25/2018
• Supplement Dates FDA Received: 09/25/2018; 09/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2017
• 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 Age: 26 YR