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

Catalog Number	8065977763
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product evaluation: product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.The iol product history records were reviewed and documentation indicates the product met release criteria.Root cause has not been identified.Additional information has been requested.(b)(4).
Event or Problem Description
A doctor reported that a lens shot out of an injector causing a capsule to rupture during an intraocular lens (iol) implant procedure.The surgery was completed after removing the iol without product replacement.In the surgeon's opinion, too much viscoelastic was applied to the iol and did not use the appropriate cartridge for the high powered lens that was used.The sample is not available because it was discarded.
Additional Manufacturer Narrative
Product evaluation: the complaint samples were not returned.Only the iol carton with the inserts was returned.The customer indicated the use of a non-qualified 28.0 diopter lens.The lens is only qualified for the cartridge for diopters 6.0 to 25.0.The customer indicated a handpiece, which is not qualified for cartridge use.The indicated viscoelastic is not qualified for lens/cartridge combinations.The root cause for the reported events appears to be related to a failure to follow the dfu.The 28.0 diopter lens is outside the qualified range of 6.0 to 25.0 for the cartridge.In addition, a non-qualified handpiece and viscoelastic were also indicated.The use of non-qualified combinations may result in delivery issues and/or damage.(b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 6911272
• Report Number: 1119421-2017-01178
• Device Sequence Number: 12528742
• Product Code: MSS
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Other Device ID Number: 00380659777639
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AE-9063OSP
• Outcome Attributed to Adverse Event: Other; Required Intervention