MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that a foreign material was found to be adhered to the backside of the intraocular lens (iol) after implanting; this was noted in three cases.The foreign material was able to be removed by aspirating with the irrigation and aspiration.The surgery was completed and the lenses remain implanted.Additional information received; the surgeon additionally suspects the cartridge as contributory.There are multiple reports for this event, this represents the iol for patient (b)(6) and additional reports will be filed.

Manufacturer Narrative

Product evaluation: the lens was not returned.The lens remains implanted.A video was provided.The cartridge preparation was not shown.Viscoelastic amount could not be determined.The lens was loaded with narrow tip forceps.A different set of forceps was used to rapidly advance the lens in the cartridge.The cartridge tip was inserted into the incision.The lens was rapidly advanced from mid-nozzle into the eye.After the lens unfolds, a strip of material was observed on the right side of the posterior surface.The material was removed with the i/a tip.The indicated cartridge is qualified for this lens model/diopter.A non-qualified handpiece/viscoelastic combination was indicated.Root cause: the root cause for the reported foreign material could not be determined.The lens and foreign material were not returned for evaluation.No determination can be made without physical evaluation of the complaint sample.The provided video was reviewed.A strip of material was observed on the posterior surface, which appeared to be in correlation to the observed edge damage.The edge damage appeared to have been caused by a plunger override.Based on the review of the provided video, the observed material may have been internal coating material from the cartridge.A non-qualified handpiece/viscoelastic combination was indicated.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10611061
• MDR Text Key: 209333802
• Report Number: 1119421-2020-01354
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WFA205
• Device Lot Number: 12713157
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AE-9036SP; MONARCH III D CARTRIDGES, 8065977763, HWV; OPEGAN; AE-9036SP; MONARCH III D CARTRIDGES, 8065977763, HWV; OPEGAN
• Patient Outcome(s): Required Intervention