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

Model Number	003500-0019-746
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	11/01/2016
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 discarded by the account; therefore, a failure analysis of the complaint device could not be completed.Refractive issues are known to be caused by numerous factors including, but is not limited to: incorrect positioning of the lens inside the eye (decentration or lens placed upside down).Wrong selection of incorrect iol regarding refractive power.Iol properties.Patient pathology/ eye characteristics changes that can be caused by previous surgeries.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.Use of the additional stent 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 ct lucia 24.5d lens was implanted.On (b)(6) 2016 the lens had to be explanted as it was reported that the wrong diopter had been implanted and it was then replaced with a ct lucia 20.5 lens.There was no adverse patient sequelae and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
It was reported that on (b)(6) 2016 a wrong diopter lens was implanted.The lens was explanted on (b)(6) 2016 replaced with a new lens.There was no adverse patient sequelae and there was no reported clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that on (b)(6) 2016 a wrong diopter lens was implanted.The lens was explanted on (b)(6) 2016 replaced with a new lens.There was no adverse patient sequelae and there was no reported clinically significant delay in the procedure.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: 6136798
• Report Number: 3010126268-2016-00010
• Device Sequence Number: 13508905
• Product Code: HQL
• UDI-Device Identifier: 00884872025435
• UDI-Public: (01)00884872025435(17)180416(10)1136321305
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2018
• Device Model Number: 003500-0019-746
• Device Catalogue Number: EC_3 PAL
• Device Lot Number: 130517
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2016
• Supplement Report FDA Received Date: 05/12/2017
• 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; Disability
• Patient Age: 75 YR