MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number	PCB00
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If explanted; give date: n/a (not applicable).The intraocular lens remains implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that upon insertion of the intraocular lens (iol) under the surgical microscope, the doctor noticed some irregularities on the posterior edge of the iol, close to but not on the haptic-optic junction.The doctor tried to aspirate/rub these ¿¿fiber-like¿¿ asperities without success.The surgery was normally performed.Provisc was used as viscoelastic.There was no patient injury reported.Patient outcome was normal.There were no patient symptoms.The iol remains implanted.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 10/25/2017.Device returned to manufacturer: yes.Device evaluation: the lens remains implanted; therefore, it was not returned and could not be investigation.The preloaded device system was returned for evaluation.The plunger was observed in the advanced position and locked.The cartridge was correctly engaged into the lower body of the pcb00 device.No assembly error and/or defect related to the manufacturing process was observed.Visual inspection at 10x microscope magnification was performed.The pushrod was exposed out of the cartridge.No defect/damage related to the manufacturing process was observed in the preloaded device system.No lens was returned for evaluation (it remains implanted); therefore, the reported issue could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6889447
• Report Number: 2648035-2017-01696
• Device Sequence Number: 10792256
• Product Code: HQL
• UDI-Device Identifier: 05050474558380
• UDI-Public: (01)05050474558380(17)200330
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/30/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000260
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1