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

Model Number	003500-0020-266
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2017
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 device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.A review of the device history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the lens.However, the use of the additional lens to correct the patient's vision is considered medical intervention to prevent permanent impairment to the patient.Markings from the folder or injector are known to be caused by numerous factors including, but not limited to: loading strategy, lens placement technique, accessory device support, poor handling during folding and inserting.
Event or Problem Description
It was reported that after implantation of an ec-3 pal lens a scratch was noted on the optic area; thus, the lens was explanted.Another lens was implanted to successfully complete the procedure.There was no adverse patient effect or any clinically significant delay in the procedure reported.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information.The lens was received and reported scratch was confirmed.It was reported that our recommended z28 cartridge and r28 injector system was used to deliver the lens.The technician is said to have over 10 years experience; however, might have caused the scratch during loading.We know that there was no damage noted to the lens during the inspection prior to use or during preparation for use, which indicates that a product deficiency did not contribute to the reported issues.Additionally, lenses are 100% inspected before they leave our manufacturing site.Therefore, we are confident that the lens was processed per standard operation procedures and inspections, and met all of the criteria for release.Markings from the folder or injector are known to be caused by numerous factors including, but not limited to: loading strategy, lens placement technique, accessory device support, poor handling during folding and inserting.The device history records were reviewed and there were no non-conformities or deviations noted during the manufacturing of the lens that would have contributed to the nature of this complaint.The dfu provides precautions for the lens handling and injection process by stating that: "improper handling of this lens may cause damage to the haptics and the optics." we have reviewed the information provided and at this time there is no indication of a product quality issue with the respect to the manufacturing, design, or labeling of the lens.No malfunction of the lens can be confirmed to have caused or contributed to the reported issue.The reported issue appears to be related to a user error during loading.
Event or Problem Description
It was reported that after implantation of an ec-3 pal lens a scratch was noted on the optic area; thus, the lens was explanted.Another lens was implanted to successfully complete the procedure.There was no adverse patient effect or any clinically significant delay in the procedure reported.

• Brand Name: EC-3 PAL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AAREN SCIENTIFIC; 1040 s vintage ave. bld. a; ontario 91761
• MDR Report Key: 6888777
• Report Number: 3010126268-2017-00004
• Device Sequence Number: 495909
• Product Code: HQL
• UDI-Device Identifier: 00884872025305
• UDI-Public: (01)00884872025305(17)220228(10)3S1702860248
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 11/10/2017

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: 02/28/2022
• Device Model Number: 003500-0020-266
• Device Catalogue Number: 003500-0020-266
• Device Lot Number: 3S170286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 11/10/2017
• 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: Required Intervention