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 Codes	Capsular Bag Tear (2639); No Code Available (3191)
Date of Event	03/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intraocular lens was removed and replaced during the same procedure.(b)(4).Device evaluation: the product was not returned for evaluation.The reported complaint was not 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 adequately provide instructions and precautions along with warnings for the proper use and handling of the device.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.
Event or Problem Description
It was reported that the preloaded pcb00 device had a damaged distal end of the cartridge and the posterior capsule ruptured.The tip of the cartridge was deformed/ cracked.The surgeon states that the damaged distal tip of cartridge led to the posterior capsule break when she rotated the injector to manipulate the intraocular lens (iol) in the bag.The iol was removed and discarded by the customer.The procedure was completed successfully with a backup iol.The surgeon enlarged the incision to remove the iol without cutting it.No vitrectomy.No additional medical or surgical intervention required.Patient is doing well.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 04/28/2017.Device returned to manufacturer ¿ yes.Device evaluation: the pcb00 preloaded insertion system was returned to the manufacturer.The plunger component was observed in a fully advanced position.Cartridge was observed correctly engaged into lower body of the pcb00 device.Visual inspection at 10x microscope magnification was performed and no lens was observed inside the unit.Evidence of viscoelastic residue was observed at the cartridge tube/tip.Stress marks in the cartridge tube and tip were observed.The cartridge tip was observed deformed confirming the reported tip damaged.No crack defect was observed.The evidence observed in the returned delivery system is consistent with a unit where an intraocular lens had passed through the cartridge.The reported issue of tip crack was not verified on the return.However, tip deformed was confirmed.All pertinent information available to the manufacturer 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: 6478406
• Report Number: 2648035-2017-00655
• Device Sequence Number: 16263245
• Product Code: HQL
• UDI-Device Identifier: 05050474558410
• UDI-Public: (01)05050474558410(17)200118
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2017

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: 01/18/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2017
• Supplement Report FDA Received Date: 06/06/2017
• 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: 83 YR