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

Model Number	Z9002
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: unknown as information was not provided.Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.Should additional information be received regarding this event the case will be reopened and processed accordingly.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the intraocular lens (iol) was inserted in to the patient's ocular dexter (right eye) and the plunger overrode the lens damaging the haptics.The lens was removed and there was no incision enlargement.Outcome does not significantly interfere with activities of daily life.No further information is available.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly: section d9: device available for evaluation? yes; section d9: returned to manufacturer: yes; 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 loading.Haptic damage was observed, on the lens.The lens was cleaned, and scratches and lens damage were observed.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 records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: (do not edit) a search revealed, that no other complaints have been received for this production order (po) number.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL 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: 11980085
• Report Number: 2648035-2021-07907
• Device Sequence Number: 4256917
• Product Code: HQL
• UDI-Device Identifier: 05050474530683
• UDI-Public: (01)05050474530683(17)250903
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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
• Report Date (Section B): 07/26/2021

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: 09/03/2025
• Device Model Number: Z9002
• Device Catalogue Number: Z900200195
• 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: 05/14/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1