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

Model Number MICL12.6

Device Problems Failure to Read Input Signal (1581); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 07/15/2014

Event Type  malfunction  

Event Description

The reporter stated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens in the patient's right eye (od) on (b)(6) 2014.The surgeon noted the lens was too large for the patient's eye, so the lens was removed on (b)(6) 2014 with no patient injury.The lens was exchanged for a shorter lens.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

(b)(4): 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 one haptic torn, with a piece torn off and missing.The lens was returned in liquid.Conclusions - 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

(b)(4).

Event Description

Additional information received - the reporter indicated upon insertion of the lens, the surgeon noted the lens was too large for the patient's eye.The lens was not fully inserted into the eye and was removed during the same surgery.There was no patient injury or adverse evernt.The patient is doing well but vision is smokey compared to left eye.The patient's va is 20/30+.

• Brand Name: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker ave; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker ave; monrovia CA 91016
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4011135
• MDR Text Key: 4959307
• Report Number: 2023826-2014-00638
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/17/2014

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: 12/31/2015
• Device Model Number: MICL12.6
• Other Device ID Number: DIOPTER -11.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 08/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2014
• 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 AND LOT NUMBER UNK; CARTRIDGE MODEL AND LOT NUMBER UNK; FOAM TIP PLUNGER MODEL AND LOT NUMBER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Weight: 56