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

Catalog Number 8065977762

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem Visual Impairment (2138)

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.Initial reporter zip code is not indicated at this time.(b)(4).

Event Description

During intraocular lens (iol) implant surgery, a physician reported a cartridge to have an iol stuck in it.The cartridge damaged the iol's optic.The iol was implanted and the patient has noticed evident vision impairment.The device remains implanted.Additional information has been requested.

Manufacturer Narrative

Two cartridges were returned.The returned pouch is for lot 32395407.One cartridge was returned in the lens pouch which has "rugosidad interna 12/05/16" written on it.This appears to be the complaint sample.The second cartridge was taped inside the pouch with "normal 12/05/16" written on it.This appears to be a comparison sample.Cartridge #1: a small amount of viscoelastic is observed in the cartridge.The cartridge has been placed into a handpiece.It is unknown at what point the lens became stuck.No damage is observed.Cartridge #2 (normal): a small amount of viscoelastic is observed in the cartridge.The cartridge has been placed into a handpiece.No damage is observed.Top coat dye stain testing was conducted with both of the returned product.The results for cartridge #1 did not meet release criteria.Cartridge #2 results were acceptable.A photo was provide of an iol in situ.There appear to be several scrape marks on the iol.The root cause for the reported complaint is an insufficient amount of top coat coverage in the returned device.This was confirmed through top coat dye-stain testing of the returned cartridge.Manufacturing records demonstrate the lot passed in-process qc testing for the presence and adequacy of top coat.Manufacturing records demonstrate the lot passed in-process qc functional testing.(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C
• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5751280
• MDR Text Key: 48970931
• Report Number: 1119421-2016-00933
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K112977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 8065977762
• Device Lot Number: 32395407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• 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): Other