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

Model Number MICL13.7

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

Patient Problems Pulmonary Regurgitation (2023); No Code Available (3191)

Event Type  Injury  

Event Description

The reporter stated the surgeon implanted a 13.7mm micl13.7 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.Subsequently, the patient experienced pupillary block and elevated intraocular pressure (iop).The reporter stated for the first two days post-op, the lens had a mild vault and the surgeon enlarged the peripheral iridectomy, but with no success.The lens was exchanged for a shorter lens.The surgeon felt the event was not due to the icl, it was more of an issue with poor sizing.The reporter stated the lens was discarded.

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.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).Lens was discarded.

Manufacturer Narrative

Method: medical review.Results: per medical review - reportedly, by a surgeon, the icl (13.7 mm long) was explanted/exchanged, two weeks postoperatively, for a different length icl (13.2 mm) to address excessive vaulting and subsequent pupillary block and elevated iop.No reported postoperative sequelae.Before lens exchange the surgeon enlarged pis but the issue was not resolved.According to the surgeon the reported event was attributed to the pre-operative procedure (measurements).Conclusions: based on the complaint history, work order search and the medical review, a probable cause of the event has been attributed to the pre-operative procedure (measurements).(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: 3907603
• MDR Text Key: 4586944
• Report Number: 2023826-2014-00489
• 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: 06/06/2014

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: 10/31/2014
• Device Model Number: MICL13.7
• Other Device ID Number: DIOPTER -12.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 07/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2012
• 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: 24 YR