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

Model Number MA60AC

Device Problem Material Opacification (1426)

Patient Problems Hemorrhage/Bleeding (1888); Hyphema (1911); Loss of Vision (2139)

Event Date 05/13/2019

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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that following an intraocular lens implant procedure, the patient experienced a sudden vision loss, vitreous hemorrhage and total hyphema.The surgeon discontinued anticoagulants and performed a pars plana vitrectomy postoperatively.The surgeon reported the vitreous hemorrhage has cleared, but the patient has had a few "re-bleeds" following the vitrectomy procedure.The iol has also become opaque.The surgeon also suspects ugh (uveitis, glaucoma, hyphema) syndrome associated with the sulcus lens.Additional information has been received indicating the iol was exchanged for another lens.

Manufacturer Narrative

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).

Manufacturer Narrative

The lens was returned in a dry condition inside a small plastic sealed container.The anterior optic surface is adhered to the interior side wall of the container.Dried solution/matter was observed on the lens haptics and optic.The optic has two large areas of unknown, slightly opaque colored matter.One of these areas of matter is stretched across the anterior optic surface, extending onto one haptic.The other large area of matter is located on the posterior optic surface along the edge and stretching toward the optic center.The optic is scratched near the center.Three impressions similar to an instrument used to grasp a lens are observed on the optic edge leading inward, near the 12 0'clock position.A gouge/crack with the shape of an instrument used to grasp a lens is also observed near the 10 0'clock position of the optic edge leading inward.Very small particulate are also observed.The lens was cleaned with lphse for further evaluation.The unknown matter on the optic surface was removed easily with cleaning.Light scratches and small amount of tiny imbedded particulate were observed after cleaning.The lens material appears clear, post cleaning.The lens was allowed to air dry for a final evaluation.The lens material does not appear to be opaque.Product history records were reviewed and the documentation indicated the products met release criteria.The explanted lens pre-cleaning and post cleaning shows no signs of discoloration or opacification in the iol.The root cause cannot be determined for the complaint of "lens went opaque".The lens has damage and dried matter observed.The lens was cleaned and allowed to air dry.The lens appears clear after the removal of the solution and dried matter from the lens.It is unknown if the dried matter observed upon both sides of the optic was interpreted as the lens material becoming opaque.The head of global quality customer affairs & communications reviewed retro-illumination images of the lens while in the eye prior to the exchange which show uniform in color and intensity throughout the iol.The lens was explanted and returned.The head of global quality customer affairs & communications reviewed photos of the explanted returned lens in both a pre-cleaned and post cleaned state: images of the lens in a dry state prior to decontamination and cleaning show material located on the surface of the iol, noting that there was no signs of discoloration or opacification in the iol material.Images of the lens is a dry state post decontamination and cleaning show a clear iol with no signs of discoloration or opacification.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8691472
• MDR Text Key: 147773032
• Report Number: 1119421-2019-00866
• 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,Followup
• Report Date: 09/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2007
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.215
• Device Lot Number: 723387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 06/26/2019; 08/19/2019
• Supplement Dates FDA Received: 07/20/2019; 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR