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

Model Number	PCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.(b)(6).(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that when the surgeon implanted the intraocular lens (iol), she had to use more force to screw the plunger than usual and after the iol entered the eye she discovered a big star shaped damage on the lens back surface.She then cut the lens into small pieces, removed and replaced it.An incision enlargement was performed.The patient had 20/20 vision, the week after surgery.There were no sutures or vitrectomy.The removed lens was discarded by the surgical staff.It was stated during follow up that there was no foreign material on the lens and the area outside the ''star shaped'' zone appeared to be intact.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device evaluation: the lens was discarded as stated the initial report; therefore, no sample evaluation was possible.The complaint reported cannot be confirmed.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 johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: the video taken during the procedure was evaluated and it was concluded that there is a possibility of component miss alignment.Based on this the complaint reported was confirmed.However, another root cause could be the inadequate use of viscoelastic.All pertinent information available to johnson & johnson surgical vision, inc.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: 7268168
• Report Number: 2648035-2018-00236
• Device Sequence Number: 11105714
• Product Code: HQL
• UDI-Device Identifier: 05050474558113
• UDI-Public: (01)05050474558113(17)190628
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• 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,Followup
• Report Date (Section B): 05/15/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/28/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000125
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 02/16/2018; 04/16/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/15/2018; 05/16/2018
• 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