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

Model Number	003500-0020-266
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Optical Problem (3001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2017
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.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.It was reported that yamane procedure was used to implant the lens.A yamane procedure is a technique used for performing sutureless intra-scleral fixation of a posterior chamber intraocular lens (iol).The haptics of the iol are externalized with a 27-gauge needle and passed through the ciliary sulcus using a double needle technique.This invasive iol fixation technique requires a lot of manipulation to position the haptics into the scleral tunnel.This lens is intended to be implanted in the capsular bag; therefore, this lens was used off-label.It is believed that this type of technique induces a large amount of force while trying to position the haptics in the scleral tunnel.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 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.
Event or Problem Description
It was reported that an ec-3 pal lens was loaded, prepped and implanted.Yamane procedure was used to implant the lens; however, it was noted that the lens haptics kept torqueing and not allowing the lens to be properly positioned in the eye.After multiple attempts with manipulation, it was noted that one of the haptics had been torn off.The lens was removed and another aaren lens implanted to successfully complete the procedure.A slight delay in the procedure was reported; however, the delay is not considered clinically significant as the patient is doing well and there was no adverse patient effects.No additional information was provided.

• 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: 6403608
• Report Number: 3010126268-2017-00001
• Device Sequence Number: 16152088
• Product Code: HQL
• UDI-Device Identifier: 00884872025305
• UDI-Public: (01)00884872025305(17)210531(10)3S1606430154
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/08/2017

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: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 003500-0020-266
• Device Catalogue Number: EC_3 PAL
• Device Lot Number: 3S160643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 03/14/2017
• 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
• Patient Age: 76 YR