MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) had bent/broken haptic during yamane technique.The iol was fully inserted and then immediately removed through the original incision and replaced during the same procedure.No other information was provided.
Additional Manufacturer Narrative
H10.Corrected data - upon further review, it was determined that section h4.Device manufacture date in the initial report was incorrect.Therefore, this correction report is to change section h4: device manufacture date to sep 20, 2020.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional info: section d9.Device available for evaluation? yes returned to manufacturer: yes date returned to manufacturer: june 9, 2021.Section h3.Device evaluated by manufacturer? yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, a detached haptic was also observed, both of which is consistent with a lens that was handled during removal.The lens was cleaned, a scratch was observed on the optic body, but this may be attributed to handling and cannot be confirmed to be related to manufacturing.The complaint issue was confirmed; however, this can be attributed to handling and cannot be confirmed to be related to manufacturing, and therefore no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints have been received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11891824
• Report Number: 2648035-2021-07884
• Device Sequence Number: 1390022
• Product Code: HQL
• UDI-Device Identifier: 05050474529151
• UDI-Public: (01)05050474529151(17)250920
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2021

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: Health Professional
• Device Expiration Date: 09/20/2025
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/24/2021; 06/28/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/27/2021; 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1