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

Model Number VICMO13.2

Device Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913); Torn Material (3024); Device Handling Problem (3265)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 09/27/2016

Event Type  Injury  

Manufacturer Narrative

Pma/510(k): n/a this product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2 mm vicmo13.2 implantable collamer lens, -15.50 diopter in to the patient's left eye (os) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to being implanted upside down and then broken during explant.The lens was exchanged for a lens the same size, model and diopter and the problem was resolved.

Manufacturer Narrative

Device evaluation: product evaluation found that the lens was returned dry in the lens case/vial with clear surgical residue/debris on product.Visual inspection found the haptic torn.Conclusion: per dfu for this lens model, vicl's are contraindicated of implantations of a lens in patients under the age of 21 years old.Corrected data: it is an adverse event, not a product problem.Previous code not applicable, no torn material associated with a material integrity issue.(b)(4).

• Brand Name: ICL (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: 6077649
• MDR Text Key: 59116200
• Report Number: 2023826-2016-01565
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 10/11/2016

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: VICMO13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR