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

Model Number MICL12.6

Device Problems Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problems Cataract (1766); Intraocular Pressure Increased (1937); Pain (1994); Swelling (2091); Numbness (2415)

Event Type  Injury  

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 lens was explanted on (b)(6) 2014 due to excessive vaulting, elevated intraocular pressure (43mm hg) and the patient complained of pain, numbness and swelling of the face.There was some cortical change (opacity) in the eye.The lens was exchanged for a shorter lens and the intraocular pressure was 24mm hg.The patient is doing well - 20/25 uc.The reporter stated the cause of the vaulting was the patient's measurements were borderline and the surgeon decided to use the longer lens (surgeon's decision).

Manufacturer Narrative

(b)(4).Evaluation codes: 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 no visible damage to the lens.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

Results: the lens was rehydrated in bss for re-measurement.The lens length was measured and the result of the measurement was compared against the original value and the lens was found to be in specification.(b)(4).

Manufacturer Narrative

Conclusions: based on the complaint history, work order search, medical review and the evaluation of the returned product, the most likely cause of the event was procedure related factor (biocalculation/user error).(b)(4).

Manufacturer Narrative

Method: medical review.Results: per medical review - reportedly icl (12.6 mm) was explanted/exchanged for a shorter length icl (12.1 mm) one week postoperatively to address lens vaulting and subsequent elevated iop.After uneventful secondary intervention patient status improved and uva was 20/25.According to the report from the facility, dated on (b)(6) 2014, the most likely cause of the event was procedure related factor (biocalculation/user error).Given the information that after implantation of a shorter lens, the overvaulting resolved, this event was not device related in origin.Conclusions: based on the complaint history, work order search, medical review and the evaluation of the returned product, the most likely cause of the event was procedure related factor (biocalculation/user error).(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: 3803430
• MDR Text Key: 4364562
• Report Number: 2023826-2014-00353
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2014

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: 09/30/2015
• Device Model Number: MICL12.6
• Other Device ID Number: DIOPTER -10.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2014
• Initial Date FDA Received: 05/09/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/21/2014; 08/08/2014; 08/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2013
• 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
• Treatment: FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL MSI-PF - LOT NUMBER UNK; CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR