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

Model Number MICL13.2

Device Problems Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problems Intraocular Pressure Increased (1937); Swelling (2091); Blurred Vision (2137)

Event Type  Injury  

Event Description

The reporter stated the surgeon explanted a 13.2mm micl13.2 implantable collamer lens on (b)(6) 2014 due to the lens having been implanted upside down.The patient complained of blurred vision and the intraocular pressure was elevated.The patient reported for four days post-op after the initial surgery, there was swelling in his eye.A new incision was created to explant the icl and another same model/diopter lens was implanted.There was some corneal edema post-op but the patient is now stable and pressure is good.The icl was initially implanted by another physician in (b)(6).

Manufacturer Narrative

Pt weight: unk.Date of event: 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 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

Method: medical review.Results: per medical review - reportedly, icl was explanted/exchanged three weeks postoperatively to address user error (upside-down implantation) and subsequent postoperative sequelae (elevated iop, corneal edema).Lens was explanted by a different surgeon and according to his report, dated on (b)(6) 2014, upon icl exchange for another icl, of a same size and diopter, patient status improved and iop was within the normal range.The dfu under visian icl handling precautions instructs physicians that: "7.The visian icl should be carefully examined in the operating room prior to implantation ".Conclusions: based on the complaint history, work order search, medical review and the evaluation of the returned product, a possible cause of the event is user error (upside-down implantation).(b)(4).

• 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: 3959040
• MDR Text Key: 16452131
• Report Number: 2023826-2014-00494
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2014

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?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2015
• Device Model Number: MICL13.2
• Other Device ID Number: DIOPTER -8.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 07/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR