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

Model Number MICL13.2

Device Problem Fitting Problem (2183)

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

Event Date 05/01/2014

Event Type  malfunction  

Event Description

The reporter stated the surgeon inserted a 13.2mm micl13.2 implantable collamer lens but had a difficult time positioning the lens into the sulcus due to the lens was too long.The lens was removed within the same surgery with no patient injury and a smaller lens was implanted (12.6mm).That lens was explanted one month later as also being too long.The reporter stated, using a ubm machine, it was noted the patient had micro-cysts in the sulcus, which were causing the lenses not to fit in the eye.The surgeon did not implant another lens, the patient is now wearing contact lenses.The reporter stated the cause of the event was patient related.

Manufacturer Narrative

(b)(4) - no known impact or consequence to patient; difficult to position.Evaluation method: work order search.Results: a lens work order search was performed and no similar complaints were found within the work order.Visual inspection of the returned product found a piece of one haptic torn off and missing.The lens was returned dry and there was evidence of clear surgical residue.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Corrected information received - the reporter stated the surgeon inserted a 13.2mm micl13.2 implantable collamer lens but had a difficult time positioning the lens into the sulcus due to the lens was too long.The lens was removed within the same surgery with no patient injury and a smaller lens was implanted (12.6mm).The reporter stated, using a ubm machine, it was noted the patient had micro-cysts in the sulcus, which were causing the lens not to fit in the eye.The reporter stated the cause of the event was patient related.

• Brand Name: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-25 60; SZ CH-2560
• Manufacturer (Section G): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-2 560; SZ CH-2560
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 3929856
• MDR Text Key: 4530821
• Report Number: 2023826-2014-00524
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2014

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: 03/31/2015
• Device Model Number: MICL13.2
• Other Device ID Number: DIOPTER -11.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 07/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2013
• 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: 43 YR