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

Model Number	EC-3 PAL
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for evaluation; however, the injector was not received.After analysis of the lens, the broken haptic was confirmed.It has been concluded that the haptic tearing could have resulted from mishandling of the lens during removal from the lens holder, possibly by pulling on the haptic.All lenses go through a 100% visual inspection for any kind of damage on the lens prior to product being released for distribution.Broken haptics such as this would not have passed inspection.Based on the information provided and without the injector to examine, the reported difficulties appear to be related to handling and prepping of the lens before the procedure and not a product quality issue with respect to manufacture, design or labeling and the treatment appears to be related to the operational context of the procedure.However, the use of an additional lens and need to enlarge the lens is considered medical intervention to prevent impairment/damage to the patient.A review of the lot 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.
Event or Problem Description
It was reported that during a procedure, it was noted that the trailing haptic broke off when the lens was being inserted into the eye and remained stuck inside the injector.The lens was explanted, the wound was enlarged to remove the lens, and sutures used to close the wound.No posterior or anterior capsule tear was reported.Another lens was implanted to successfully complete the procedure.There were no reported adverse patient sequelae.

• Brand Name: AAREN SCIENTIFIC
• Common Device Name: EC-3 PAL
• Manufacturer (Section D): AAREN SCIENTIFIC INC; 1040 s vintage av bld. a; ontario CA 91761
• MDR Report Key: 5636084
• Report Number: 3010126268-2016-00004
• Device Sequence Number: 167343
• Product Code: HQL
• UDI-Device Identifier: 00884872025404
• UDI-Public: (01)00884872025404(17)20161101(10)1173621406
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P100016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: EC-3 PAL
• Device Catalogue Number: EC-3 PAL
• Device Lot Number: 140627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2014
• Initial Report FDA Received Date: 05/05/2016
• 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
• Patient Age: 64 YR