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

Model Number	PCB00
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: n/a (not applicable).The intraocular lens was not explanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a plastic piece/deposit was found in the anterior chamber (ac) post implantation of the intraocular lens (iol) in the patient¿s left eye.Neither the surgeon nor the nurse can identify the origin of the plastic matter.The surgeon used forceps to remove the particle from the patient¿s eye.There was a small hemorrhage at wound site.The iol remains implanted.There was no incision enlargement, no sutures, no vitrectomy.It was stated that the patient outcome is normal, and that the small hemorrhage was controlled with slight pressure.There was no need for any additional medical or surgical intervention.In addition, a plunger rod issue was reported.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 4/22/2017.Device returned to manufacturer? yes.Device evaluation: according to the visual inspection performed, the device system and the lens were not returned.Only the reported piece of plastic was received for evaluation.Based on fourier transform infrared spectroscopy (ftir) analysis, the particles was identified as polypropylene.Based on energy-dispersive x-ray spectroscopy analysis, particle shows the presence of carbon (c), oxygen (o), sodium (na) and chlorine (cl), with traces of magnesium (mg), silicon (si), phosphorus (p), potassium (k) and calcium (ca).These results are consistent with the presence of a salt solution on an organic material (i.E.Plastic), with other biological constituents.The reported issue was 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) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.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: 6517681
• Report Number: 2648035-2017-00734
• Device Sequence Number: 760682
• Product Code: HQL
• UDI-Device Identifier: 05050474558380
• UDI-Public: (01)05050474558380(17)190912
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2017

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: Physician
• Device Expiration Date: 09/12/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 05/31/2017
• 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: 88 YR