MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; MONOFOCAL IOLS

Model Number	ZA9003
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2016
Type of Reportable Event	Malfunction
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.Phone/facility name/address/city/state/postal code/country: unknown/ not provided.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was stuck and tore during insertion.The iol was removed and replaced with another one.There was a delay of about 5-10 minutes.There was no patient injury reported.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device evaluation: the device 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 investigation request 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.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 6/1/2017.Device returned to manufacturer? yes.Conclusions code: removed code 67 as the device was returned and the reported issue was confirmed.Device evaluation: the complaint unit was received for evaluation.Visual inspection at 10x microscope magnification was performed.Loose particles/fibers in the optic body were observed compatible with handling the lens out of a sterile environment.Residues of lubricant such as ophthalmic viscoelastics (ovds) were observed in the lens optic body.One lens haptic was observed detached.The detached haptic piece was not returned.The lens optic was observed cut, ripped/torn.The condition observed in the lens is consistent with a lens that has been handled and prepared for use.The reported issue was verified in the returned sample.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6591587
• Report Number: 2648035-2017-00941
• Device Sequence Number: 1266655
• Product Code: HQL
• UDI-Device Identifier: 05050474529090
• UDI-Public: (01)05050474529090(17)210503
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P990080
• 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): 07/19/2017

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: 05/03/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: Not provided; 06/27/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 06/23/2017; 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1