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

Model Number ASKU

Device Problem Failure to Align (2522)

Patient Problems Corneal Edema (1791); Glaucoma (1875); Hyphema (1911); Intraocular Pressure Increased (1937); Uveitis (2122); Blurred Vision (2137); Eye Pain (4467)

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.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.Alshehri m, al beshri a, bamefleh d (b)(6) 2023 haptic amputation under endoscopic guidance in uveitis-glaucoma-hyphema syndrome: a case report.Cureus 15(3): e36303.Doi 10.7759/cureus.36303 the manufacturer internal reference number is: (b)(6).

Event Description

A case study on haptic amputation under endoscopic guidance in a one eyed patient with uveitis-glaucoma-hyphema (ugh) syndrome showed that the patient's right eye (seeing eye) had mild to moderate ocular pain associated with a gradual decrease of vision over two years, which started getting worse in the last two months.Patient had no history of previous ocular trauma, pre-existing glaucoma, or chronic use of ocular drops.Slit lamp examination for the right eye (figure 1) showed mildly injected conjunctiva and moderately diffuse corneal oedema with signs of anterior uveitis, including 2+ cells, flare, and pigments with 1 mm height of hyphema with no further view behind.The patient was diagnosed with right uveitis-glaucoma-hyphema (ugh) syndrome secondary to a subluxated intraocular lens (iol).The patient was admitted to the ward and started on topical atropine sulphate 1% three times a day (off label use), prednisolone acetate 1% every four hours, and full anti-glaucoma drops, including brimonidine 0.2%, timolol maleate 0.5%, brinzolamide 1%, and bimatoprost 0.01%.The patient noticed that ocular pain was less in severity but with a similar clinical picture and the intraocular pressure (iop) was still high at 34 mmhg.It was decided to increase the frequency of steroid drops to every two hours and to add acetazolamide 250 mg tablet twice daily after getting medical clearance.Washed ovd and closed the wounds with stromal hydration and the main wound using 10-0 nylon sutures.The iol was stable and well-centered in the bag.The patient was discharged home on atropine, steroid, timolol, and brimonidine drops in addition to diamox tablet 250 mg twice a day (bid).The patient was advised to start tapering steroid drops, stopping acetazolamide tablet, and continuing topical anti-glaucoma drops with timolol and brimonidine.Additional information has been requested.

Event Description

Upon review of the current information, this report of literature article for event of amputated haptic in relation to event of uveitis-glaucoma-hyphema (ugh) syndrome for an unspecified/unknown iol with no identifiable manufacturing information, no identified design, and no identified material does not meet reporting criteria as per applicable regulatory requirements noted in usa fda requirements for post-market surveillance applicable regulations.Follow-up actions have been taken to obtain additional product details from the author, however, no information has been received.

Manufacturer Narrative

The initial decision to report was incorrect resulting in the initial report being submitted in error.As the product is of unspecified/unknown iol with no identifiable manufacturing information, no identified design, and no identified material (not a confirmed company product).No further reports required.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16993809
• MDR Text Key: 315858786
• Report Number: 1119421-2023-00956
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ISOPTO ATROPINE 1%; MICRO-SCISSORS; MYDRANE; V-LANCE KNIVES
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Male