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

Model Number	003500-0020-268
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned and evaluated.The lens was received cut in half.Multiple indentation could be seen on the lens; however, no scratches were noted as reported.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.Based on the information provided and after product analysis, the reported issue appears to be related to the circumstances of the procedure and likely have been caused by the handling of the lens during implantation.All (b)(4) scientific lenses go through a 100% visual inspection prior to product being released for distribution.Any scratches as reported would not have passed inspection.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"; therefore, it has been determined that if the lens is not handled correctly may result in damage to the lens.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.The lens has been explanted and a new lens implanted without any further issues.The patient is doing well and there were no adverse patient sequela.
Event or Problem Description
It was reported that after implantation the lens was noted to be scratched; thus, the lens was cut in half and explanted.However, the incision did not need to be enlarge.Another lens was implanted to successfully complete the procedure.There was no adverse patient effects or clinically significant delay in the procedure.No additional information was provided.

• Brand Name: AAREN SCIENTIFIC INC.
• Common Device Name: EC-3 PAL
• Manufacturer (Section D): AAREN SCIENTIFIC INC; 1040 s vintage ave. bld. a; ontario CA 91761
• MDR Report Key: 6571367
• Report Number: 3010126268-2017-00002
• Device Sequence Number: 980738
• Product Code: HQL
• UDI-Device Identifier: 00884872025329
• UDI-Public: (01)00884872025329(17)220228(10)3S1702650200
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2017

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: 003500-0020-268
• Device Catalogue Number: EC-3 PAL
• Device Lot Number: 3S170265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2017
• Initial Report FDA Received Date: 05/16/2017
• 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