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

Model Number	003500-0020-271
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	11/12/2016
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 was not returned for evaluation as it was retained by the account; therefore, a failure analysis of the complaint device could not be completed.Broken lens and distorted haptics 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.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 and the reported issue appears to be related to the off-label use of implanting the lens using the scleral fixated/glued technique.Aaren scientific's ec-3 iol is a uv light-absorbing posterior chamber hydrophobic acrylic lens designed to be implanted in the capsular bag following extracapsular cataract extraction.This technique likely caused increased tensile forces on the haptics, which then forced the haptics to dislocate/dislodge from the optic body.Thus, it appears the issue is related to the operational context of the procedure and not a malfunction of our device.However, the use of the additional lens to correct the patient's vision is considered medical intervention to prevent permanent impairment to the patient and this report is conservatively being filed.
Event or Problem Description
It was reported that on (b)(6) 2016 a 20.5 diopter ec_3 lens was implanted.After implantation, it was noted that, the lens want to tilt but even then, the lens was left in the patient.The following day, it was noted that the haptic had completely dislodged from the optic and the haptic remained attached to the tunnel.On (b)(6) 2016, the lens was explanted and another lens implanted.There was no adverse patient effects and no reported of any clinically significant delay.No additional information was provided.User facility medwatch stated: right eye aphakia and patient no longer able to place contact lens and was admitted for secondary iol insertion with planned (scleral fixated/glued iol and anterior vitrectomy to right eye) procedure went well with no complications.On follow-up visit exam with haptics visible and in good positon; however, nasal haptic dislocated from optic ans will need to be replaced.The patient underwent removal of failed lens and replaced with another ec_3 pal lens.Post-op the patient is doing well with small home secondary tod blood thinners, expect visual acuity to improve as heme resolves.

• Brand Name: AAREN SCIENTIFIC
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AAREN SCIENTIFIC INC; 1040 s vintage ave. bld. a; ontario CA 91761
• MDR Report Key: 6176096
• Report Number: 3010126268-2016-00011
• Device Sequence Number: 452546
• Product Code: HQL
• UDI-Device Identifier: 00884872025350
• UDI-Public: (01)00884872025350(17)2107311(10)3S1608940025
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/14/2016

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: 07/31/2021
• Device Model Number: 003500-0020-271
• Device Catalogue Number: EC_3 PAL
• Device Lot Number: 3S160894
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2016
• Initial Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention