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

Model Number	PCB00
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intraocular lens was removed and replaced during the same procedure.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was inserted and appeared gouged.The surgeon said that it felt a little harder than usual to turn the screw of the lens delivery system.The end result was that the iol was removed from the eye after the surgeon cut it into 3 pieces.The incision was enlarged slightly.There was no vitreous/vitrectomy and no sutures were needed to seal the incision after a second lens was implanted.Further information was provided and noted that what may have caused the event, was there was not enough viscoelastic in the very back of the cartridge and the lens stuck and the plunger ended up digging into the optic.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Corrected data: upon further review, it was recognized that the date (08/16/2017) that was provided in date received by mfr in the initial report was incorrect.The correct date for this field is 08/15/2017.Device evaluation: the product was discarded by the customer; therefore, it was not returned for investigation.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.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: 6854299
• Report Number: 2648035-2017-01623
• Device Sequence Number: 800503
• Product Code: HQL
• UDI-Device Identifier: 05050474558182
• UDI-Public: (01)05050474558182(17)200302
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 03/02/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 01/30/2018
• 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