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

Model Number VICMO12.1

Device Problems Device Slipped (1584); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 06/05/2014

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.1mm vicmo12.1 implantable collamer lens in the patient's left eye (os) on (b)(6) 2014.The lens was explanted on (b)(6) 2014 due to low vaulting and lens rotation.The lens was exchanged for a longer lens and the problem was resolved.

Manufacturer Narrative

(b)(4): evaluation: method - work order search.Results - a lens work order search was performed and one similar complaint was 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.Claim # 706886.

Manufacturer Narrative

Method: medical review.Results: visual inspection of the returned product found one haptic torn.The lens was returned dry and there was evidence of clear surgical residue.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.Medical review - according to use fmea (failure modes and effect analysis) it has been determined that inadequate vaulting is a consequence of a wrong lens use failure mode (i.E.Improper white to white measurement, variability of the white to white measurements based upon different techniques utilized, improper sulcus to sulcus measurement (if ubm used), and patient condition; poor correlation of white to white measurement and length of ciliary sulcus in an individual case; irregular ciliary sulcus or ciliary sulcus cyst).Several factors may contribute to rotation of an icl (i.E.Patients anatomical structure, a short lens, haptic position, etc.).Conclusions: based on the complaint history, work order search, medical review and the evaluation of the returned product, a probable root cause of inadequate vaulting has been determined to be related to the inaccuracy of the white to white measurement or a mismatch between white to white and the sulcus to sulcus diameter.(b)(4).

• 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: 4111167
• MDR Text Key: 4700095
• Report Number: 2023826-2014-00741
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2014

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: 10/31/2016
• Device Model Number: VICMO12.1
• Other Device ID Number: DIOPTER -13.50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 09/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2013
• 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: CARTRIDGE MODEL AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR