MAUDE Adverse Event Report: AAREN SCIENTIFIC INC AAREN SCIENTIFIC INC.; INTRAOCULAR LENS

Model Number	003500-0020-270
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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.
Event or Problem Description
It was reported that on (b)(6) 2016 an ec-3 pal lens was prepped and loaded with the use of forceps.Upon, insertion it was noted that the lens was cracked.The lens was explanted and another same size lens was used to successfully complete the procedure.There were no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
The device is no longer returning the customer reported it has been discarded.The device was not returned for evaluation as it was discarded by the account; therefore, a failure analysis of the complaint device could not be completed.Based on the information provided, and without the product to examine, 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 aaren scientific lenses go through a 100% visual inspection prior to product being released for distribution.Any surface defects as the ones 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 by the haptic portion only while loading may result in damage to the optic body.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.Device has been discarded.
Event or Problem Description
It was reported that on (b)(6) 2016 an ec-3 pal lens was prepped and loaded with the use of forceps.Upon, insertion it was noted that the lens was cracked.The lens was explanted and another same size lens was used to successfully complete the procedure.There were no adverse patient effects.No additional information was provided.Additional information received: it has been reported that the device is no longer available for return as it has been discarded.No additional information was provided.

• Brand Name: AAREN SCIENTIFIC INC.
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AAREN SCIENTIFIC INC; 1040 s vintage av bld. a; ontario CA 91761
• MDR Report Key: 5685561
• Report Number: 3010126268-2016-00005
• Device Sequence Number: 307629
• Product Code: HQL
• UDI-Device Identifier: 00884872025343
• UDI-Public: (01)00884872025343(17)210228(10)3S1602970135
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2016

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: 02/28/2021
• Device Model Number: 003500-0020-270
• Device Catalogue Number: EC-3 PAL
• Device Lot Number: 3S160297
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2016
• Supplement Report FDA Received Date: 06/15/2016
• 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