MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON MONARCH IOL DELIVERY SYSTEM, CARTRIDGE; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number ASKU

Device Problem Material Opacification (1426)

Patient Problems Inflammation (1932); Pain (1994); Loss of Vision (2139)

Event Date 09/14/2017

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided from the account for further investigation.Follow-up information was provided by the surgeon that they do not feel that the cartridges are involved because they are used for non-preloaded monofocal iols and there was no incident with the other iols noticed by him or his colleagues.The manufacturer internal reference number is: (b)(4).

Event Description

A doctor reported that eight days following intraocular lens (iol) implantation, the patient presented with inflammation (3+ tyndall).It was noted that there was no change in the usual post-operative treatment.Inflammation had decreased to 1+ tyndall as of (b)(6) 2017 and had not complained of any functional signs.It was noted that the patient¿s other eye was operated on (b)(6) 2017 with a different implant, and there was no inflammation at the eight day postoperative visit.Additional information was received via a company representative, indicating that visual acuity loss and pain were also noted.The patient was treated with dexamethasone with neomycin, triamcinolone, and ofloxacine postoperatively.It was also reported that results were good after one month; however, six patients had posterior capsular opacification (pco) requiring yttrium aluminium garnet (yag) laser treatment at three months, but it is unclear if this patient was affected.The surgeon does not suspect that the cartridge contributed to the event.

• Brand Name: MONARCH IOL DELIVERY SYSTEM, CARTRIDGE
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7427753
• MDR Text Key: 105370065
• Report Number: 1119421-2018-00409
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 62 YR