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

Model Number VICMO13.2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hypopyon (1913); No Code Available (3191)

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 13.2mm vicmo13.2 implantable collamer lens in the patient's right eye (od) on (b)(6) 2014.The patient has been diagnosed with acute iridocyclitis and hypopyon.The patient is being prescribed medication and the lens remains implanted.

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.Pt weight: unk.Date event: unk.(b)(4).Device evaluated by manufacturer? no.Lens implanted.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

Upon review of the device history record, a conclusion can be drawn that nothing in the manufacturing and packaging processes is likely to have contributed to the complaint.Based on the information provided by the facility, the lens was not indicated to have been received damaged or defective.It is unclear if the lens itself caused or contributed to the onset of iridocyclitis and hypopyon.Therefore, no root cause can be identified.Probable causes for this event could include pre-existing patient issues or conditions.Based on the complaint history, work order search, and 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 avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 4704669
• MDR Text Key: 5722419
• Report Number: 2023826-2015-00431
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor,distributor,forei
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2015

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: 03/31/2017
• Device Model Number: VICMO13.2
• Other Device ID Number: DIOPTER -09.50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2015
• Initial Date FDA Received: 04/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2014
• 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
• Patient Age: 37 YR