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

Model Number VICMO12.6

Device Problem Human-Device Interface Problem (2949)

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

Event Date 09/26/2014

Event Type  malfunction  

Event Description

The reporter indicated the surgeon inserted a 12.6mm vicmo12.6 implantable collamer lens into the patient left (os) eye and had difficulty positioning the icl under the iris and the lens kept coming out.Removed during surgery and not replaced.

Manufacturer Narrative

This product is manufactured in (b)(4) and is not marketed in the u.S.Pt weight: unk.(b)(4).Method: work order search.Results: a lens work order search was performed and no similar complaints were found within the work order.Conclusions: (no conclusion can be drawn): based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).Lens not returned.

Manufacturer Narrative

Evaluation: method - medical review.Results - visual inspection of the returned product found one haptic torn and the lens was returned dry.The lens was rehydrated and both the length and width were remeasured and determined to be within design specifications.Medical review - there is not enough information to determine the cause of the event.Potential contributing factors: overfilled ac, not enough pupil dilation, to long lens, ect.Conclusions - based on the complaint history, work order search, medical review and the evaluation of the returned product, we were unable to determine a specific root cause of the event.(b)(4).

• Brand Name: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• Manufacturer (Section G): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4571091
• MDR Text Key: 5459355
• Report Number: 2023826-2015-00242
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2014

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: 01/31/2017
• Device Model Number: VICMO12.6
• Other Device ID Number: DIOPTER -09.50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 03/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2014
• 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
• Treatment: CARTRIDGE MODEL AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Patient Age: 40 YR