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

Model Number MICL13.2

Device Problems Defective Device (2588); Appropriate Term/Code Not Available (3191)

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

Event Date 09/24/2014

Event Type  malfunction  

Event Description

A 13.2mm micl13.2 implantable collamer lens was reported as being defective (chipped) by the facility.There was no patient contact and the backup lens was used.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Pt age: unk.Pt weight: unk.Implant date: na.Explant date: na.Initial reporter: 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.Visual inspection of the returned product found a piece of one haptic torn off and missing.The lens was returned in liquid.Conclusions: (no conclusion can be drawn): based on the complaint history, work order search and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).

Manufacturer Narrative

Evaluation: method - device history record review.Results - a review of the device history record was performed and nothing was found in the manufacturing, packaging or shipping processes of this lens that was the root cause of the complaint.Conclusions - based on the complaint history, work order search, device history record review and the evaluation of the returned product, it is the most likely root cause that the lens damage and tear was caused by handling and manipulation of the lens by the user.(b)(4).

• Brand Name: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: 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: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4215200
• MDR Text Key: 5039026
• Report Number: 2023826-2014-00896
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2016
• Device Model Number: MICL13.2
• Other Device ID Number: DIOPTER -7.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2014
• 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: INJECTOR MODEL MSI-PF - LOT NUMBER UNK; CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK