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

Model Number	003500-0020-263
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 detached haptic 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.Device has been discarded.
Event or Problem Description
It was reported that post surgery, a broken haptic was noticed.Patient was sent to a retinal specialist for exploratory surgery and lens retrieval completed.During retrieval the 2nd haptic broke off; however, it too was successfully removed from the patient's eye.No other lens was implanted and the patient was sent home aphakic.Further corrective surgery will be required to implant a new lens, but at this time no date has been scheduled.No additional information was provided.
Additional Manufacturer Narrative
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 detached haptic 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.Device has been discarded.
Event or Problem Description
Additional information was received and stated that a follow-up procedure was performed on (b)(6) 2016.The patient had the scleral fixated and another lens glued using tisseel glue.The patient reportedly is doing great and there was no reported adverse patient sequela.No additional information has been received.

• 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: 5814730
• Report Number: 3010126268-2016-00006
• Device Sequence Number: 692415
• Product Code: HQL
• UDI-Device Identifier: 00884872025275
• UDI-Public: (01)00884872025275(17)210131(10)3S1602140013
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2016

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: 01/31/2021
• Device Model Number: 003500-0020-263
• Device Catalogue Number: EC-3 PAL
• Device Lot Number: 3S160214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2016
• Supplement Report FDA Received Date: 08/18/2016
• 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