MAUDE Adverse Event Report: AAREN SCIENTIFIC EC-3 PAL; INTRAOCULAR LENS

Model Number	003500-0019-041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Unspecified Infection (1930); Patient Problem/Medical Problem (2688)
Date of Event	06/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.The lens was kept by the hospital; thus, a proper device analysis could not be completed.Factors known to contribute or cause to the development of fungal growth after cataract surgery are but not limited to: patient conditions; surgical factors; various contaminants which are usually introduced from surgical equipment or supplies within the sterile field.We have reviewed the device history records (dhr's) and sterilization reports and there were no nonconformities or deviations noted during the manufacturing of the lenses that could have contributed to the nature of this complaint.The dhr's indicate that the lenses were processed per standard operation procedures, inspections and met all of the sterilization criteria for release.Quality control confirmed that no failures of the following have occurred during the manufacturing period of these lenses: bioburden; endotoxins on the product; particulate count in clean room; air born germs (clean room and laminar flow hoods).Additionally, a query of the complaint-handling database revealed no indication of a lot specific product quality deficiency or any other fungal growth complaints with any of our ec-3 pal lenses.
Event or Problem Description
It was reported that on (b)(6) 2017, two ec-3 pal lenses were implanted into the patient's eyes.Fifteen (15) days post-operation, the patient suffered from some sort of fungal growth in her left eye.The right eye had no issues.The left eye lens was removed and fungal growth treated with antibiotics but show no improvement.The patient's vision is impacted and replacement of the lens seems not to be an option.No additional information has been provided.

• Brand Name: EC-3 PAL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AAREN SCIENTIFIC; 1040 s vintage ave. bld. a; ontario CA 91761
• MDR Report Key: 6909725
• Report Number: 3010126268-2017-00005
• Device Sequence Number: 108229
• Product Code: HQL
• UDI-Device Identifier: 00884872025381
• UDI-Public: (01)00884872025381(17)181001(10)1181391311
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/02/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 10/01/2018
• Device Model Number: 003500-0019-041
• Device Catalogue Number: 003500-0019-041
• Device Lot Number: 131115
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR