MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Chemosis (1775); Corneal Edema (1791); Endophthalmitis (1835); Hypopyon (1913); Retinal Detachment (2047); Loss of Vision (2139); Vitrectomy (2643)

Event Date 09/18/2017

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.Results from the product history record review indicated the iol met release criteria.A root cause cannot be identified at this time.(b)(4).

Event Description

A surgeon reported via a health authority that a patient experienced an enterococcus faecalis infection four days following a cataract procedure with intraocular lens (iol) implant on her right eye (od).Endophthalmitis was observed with chemosis, retinal detachment, hypopyon, and corneal edema.The patient was hospitalized for nine days and treated with intravenous antibiotics.A vitrectomy was performed on (b)(6) 2017.It was noted that antibiotic eye drops had been prescribed since the first postoperative day.It was reported that the symptoms were continuing and that functional loss of the eye occurred.This is one of two reports being filed for the same facility.

Manufacturer Narrative

The product was not returned for investigation.We are unable to confirm the reported complaint.Based on the results from the product, batch and sterilization history record, the product met release criteria.There have been no other complaints for this lot.The manufacturer internal reference number is: (b)(4).

Event Description

Clarification was received, indicating that the reporting facility cannot determine which medical device may to have contributed to the event.It was noted that no samples can be provided.The surgery was uneventful, there were no new members of the sterilization team, and there had been no recent changes in procedures.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7012170
• MDR Text Key: 91410697
• Report Number: 9612169-2017-00194
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.180
• Device Lot Number: 21155214
• Other Device ID Number: 00380655093153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• 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: 82 YR