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

Model Number SN60WF

Device Problems Device Damaged by Another Device (2915); Material Protrusion/Extrusion (2979); Device Fell (4014)

Patient Problem Capsular Bag Tear (2639)

Event Date 08/14/2019

Event Type  Injury  

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.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that during an intraocular lens (iol) implant procedure, there was an iol issue.Additional information was provided that the iol had a huge spike on it.Further information was provided by the surgeon, that the patient received an iol that contained a defect causing the posterior capsule to rupture.This surgery occurred in august.The original iol fell into the vitreous following the capsular rupture necessitating a vitrectomy and iol explantation.Two different sulcus iols were inserted with the first one also being explanted.The patient is now seeing well.Additional information was provided by the surgeon, that that the protrusion from the iol optic broke the capsule when it was injected.The patient needed a vitrectomy and iol retrieval from vitreous cavity and iol removal from sulcus.The patient is still healing.Awaiting corneal suture removal (placed during vitrectomy/iol removal procedure).The corneal suture will be removed in a few weeks if well healed.The prognosis is guarded.

Manufacturer Narrative

Product evaluation the lens was returned.Foreign matter (possibly biological) was observed near one haptic/optic junction area.The observed material has a clear gel-like appearance when removed from the liquid.This is on the surface of the lens.No lens damage or "spike" observed.The shape of the gel-like material on the edge of the lens may have been interpreted as the reported "spike".The returned product matched the provided photo.The sample was sent to the particle lab for analysis of the material.The opaque residue was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the material¿s generated ir spectra to a library of spectra finds the best match to be bovine albumin (protein material).This would indicate this is biological in nature.The specific identify cannot be determined.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause for the reported pc-tear and subsequent lens dislocation cannot be determined.The returned lens was not damaged and did not have the reported "spike".The manufacturer internal reference number is: (b)(4).

Event Description

The patient reported that the doctor had lost the iol in her eye and that she had to see a retinologist in (b)(6).Her eye is ok.

• 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: 9241860
• MDR Text Key: 163902646
• Report Number: 1119421-2019-01799
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.215
• Device Lot Number: 12679255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGES, 8065977763, HWV; UNSPECIFIED DUOVISC VISCOELASTIC; UNSPECIFIED MONARCH IOL DELIVERY SYST; UNSPECIFIED PROVISC OVD
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR