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

Model Number	PCB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The intraocular lens was removed and replaced during the same procedure.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The tip of the preloaded delivery system was found cracked during insertion.The intraocular lens (iol) was not completely delivered into the left eye, so it was removed without an issue.Another iol was used and the surgery was delayed for 15 minutes.It was reported that the cataract was yellow and level 3.The anterior chamber was good and the posterior chamber was complete.The incision was 3.00mm, no residual, no vitrectomy, the iol was centered.The pupil was round and 7mm after surgery.Best visual acuity pre-operative: 0.3.Best visual acuity post-operative:1.0.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 06/01/2017.Device returned to manufacturer? yes.Device evaluation: the complaint unit was received in its original folding carton.The plunger was observed in advanced position and the cartridge was correctly engaged into the lower body of the device.No assembly error and/or defect related to the manufacturing process was observed.The lens was returned out of the device inside an insert case that was sealed with adhesive tape.Visual inspection at 10x microscope magnification was performed.The lens was received broken.Something that appeared to be body fluid was observed on the lens surface.No cartridge crack was observed.The condition in which the lens was received indicates that the product was handled and prepared for the surgical process.The customer's 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: 6593275
• Report Number: 2648035-2017-00951
• Device Sequence Number: 369889
• Product Code: HQL
• UDI-Device Identifier: 05050474558076
• UDI-Public: (01)05050474558076(17)191206
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2017

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: 12/06/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 06/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR