MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN6AT6

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hypopyon (1913); Visual Impairment (2138)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis; the lens remains implanted.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A physician reported that five days following an intraocular lens (iol) implant procedure, a patient experienced ophthalmodynia and sudden decreased vision.A large amount of fiber precipitation was found in the pupillary zone, a little hypopyon was found.The patient was hospitalized and received subconjunctival injection of steroids, adrenaline and antibiotic treatment.The patient also received an antibiotic injection in the vitreous cavity.Additional information has been requested.Additional information was provided indicating that the patient had been discharged and was recovering.The vision was better than before, but lower that post-surgery (not specified).Due to the patient's indoor decorations and that the patient did not receive treatment as per prescription, the hospital considered the patient's outcome as related to his postoperative care.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was provided indicating that the healthcare professional reported that the endophthalmitis was not caused by the antibiotics and steroid because of the following reasons: the patient did not follow the medical advice after operation.Postoperative care was not appropriate: the patient had a neighbor who had been decorating the room at the time so the air was with more dust.#).The patient rubbed his eyes.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7029906
• MDR Text Key: 92033870
• Report Number: 1119421-2017-01304
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2020
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6.185
• Device Lot Number: 12420119
• Other Device ID Number: 00380652274302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR