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

Model Number	PCB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Explant date: if explanted; give date: n/a (not applicable).The intraocular lens remains implanted.(b)(4).Device evaluation: the lens remains implanted; therefore, it was not returned for investigation.Pictures of the lens were provided by the customer.The photos showed a lens implanted and rings on an intraocular lens were observed as stated in the initial report.However, considering that the lens is not available for a thorough evaluation, it is not possible to confirm if the lathe lines condition was related to in-line manufacturing practices/process or a result of the lens being handled by the surgery site.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.Attempts were made to obtain missing information; however, to date the information has not been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that rings (lathe lines) were evident on an intraocular lens (iol).Iol remains implanted.The patient is well.There is no affect on the patient's daily activities.No interventions were required.No additional information was provided to abbott medical optics.

• 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: 6844032
• Report Number: 2648035-2017-01600
• Device Sequence Number: 706139
• Product Code: HQL
• UDI-Device Identifier: 05050474558144
• UDI-Public: (01)05050474558144(17)200517
• 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
• Report Date (Section B): 09/05/2017

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: 05/17/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1