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

Model Number ICM120V4

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2014

Event Type  malfunction  

Event Description

The reporter indicated the surgeon was preparing to load a 12.0mm icm120v4 implantable collamer lens in the patient's right eye (od) and noted a black dot/foreign body adhesion on the lens surface.The lens was not used and there was no patient contact.

Manufacturer Narrative

No known impact or consequence to patient.Item contaminated during manufacturing or shipping.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

Evaluation: results - the dark particle on the lens was analysed and was identified as an acrylic copolymer.The particle is most likely a product of the collamer material processing.(b)(4).

Manufacturer Narrative

Evaluation: method - device history record review.Results - a review of the device history record was performed and nothing was found in the manufacturing, sterilization and packaging processes of this lens that was the root cause of the complaint.Conclusions - no conclusion can be drawn: based on the complaint history, work order search and the device history record review, a specific root cause of the event could not be determined.(b)(4).

• Brand Name: 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: 3816560
• MDR Text Key: 4403721
• Report Number: 2023826-2014-00374
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030016
• 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,Followup
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2016
• Device Model Number: ICM120V4
• Other Device ID Number: DIOPTER -20.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 05/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/17/2014; 05/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2013
• 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: INJECTOR: MODEL AND LOT NUMBER UNK; CARTRIDGE: MODEL AND LOT NUMBER UNK
• Patient Age: 31 YR