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	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight, and ethnicity: information unknown/not provided.If implanted, give date: not applicable, as lens was removed during the same procedure.If explanted, give date: not applicable, as lens was removed during the same procedure.Initial reporter first name: information unknown/not provided.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The surgery center reported defective intraocular lens (iol).The lens was inserted and removed in the same procedure.It is unknown if the procedure was completed successfully.There were no surgical intervention required.No further information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes section d9: date returned to manufacturer: jun 10, 2021 section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during removal and replacement.Haptic damage (bent) and a detached haptic were also observed but can be attributed to handling and cannot be confirmed to be related to manufacturing.The lens was cleaned, and no cosmetic defects were observed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing records review: the manufacturing records were reviewed and a nonconformance (nc) was found as part of this manufacturing records review.This nc did not contribute to the complaint event reported.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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: 11883115
• Report Number: 2648035-2021-07890
• Device Sequence Number: 1389808
• Product Code: HQL
• UDI-Device Identifier: 05050474528949
• UDI-Public: (01)05050474528949(17)231016
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 10/16/2023
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1