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 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 left eye (os) on (b)(6) 2014.The lens was explanted on (b)(6) 2014 due to excessive vaulting, elevated intraocular pressure (37mm hg) and the patient complained of pain, numbness and swelling of the face.The lens was exchanged for a shorter lens and the intraocular pressure was 28mm 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).Lens not returned.Evaluation, method: work order search.Results : a lens work order search was performed and no similar complaints were found within the work order.Conclusions - (no conclusion can be drawn): based on the complaint history and work order search, 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 for a shorter length icl, one week postoperatively, to address excessive vaulting and subsequent elevated iop.Upon lens exchange patient status improved and ucva was 20/25.According to the report by hcp, dated on 05/08/2014, the most likely cause was user error (wrong length chosen by a surgeon) and therefore not related to the device.This correlates with the literature report that placement of the oversized icl could lead to excessive vaulting.(b)(4).

Manufacturer Narrative

Results: visual inspection of the returned product found pieces of one haptic 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: device history record review.Result: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Conclusion: based on the complaint history, work order search, device history record review, medical review, and product evaluation, a specific root cause of the event could not be determined.Claim #(b)(4).

Manufacturer Narrative

Event problem and evaluation codes: method code(s): (process evaluation): device history record review.Result code(s): (failure not detected) : based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.(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-25 60; SZ CH-2560
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 3803435
• MDR Text Key: 4385190
• Report Number: 2023826-2014-00354
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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 -9.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 05/09/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/13/2014; 09/09/2014; 06/10/2016; 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2013
• 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