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	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: patient weight and ethnicity and race: unknown as information was not provided.Date implanted: not applicable, as the iol was removed/replaced during the same procedure.Date explanted: not applicable, as the iol 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 the intraocular lens (iol) was fully inserted into the patient's ocular dexter (right eye) and removed during the same procedure due to a bent/broken haptic.The procedure was completed using another iol with the same model and diopter size.Procedure outcome does not significantly interfere with activities of daily life and it was reported the patient has recovered.No further information is available.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly: section d-9: device available for evaluation: yes section d-9: date returned to manufacturer: 27-aug-2021 section h-3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens had been cut into three pieces, which is consistent with a lens handled during removal and replacement.Both haptics were also observed to be detached (one missing).Furthermore, a portion of the remaining haptic was observed to be damaged (bent).Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue can be confirmed; however, based on the return condition of the lens this 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: 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 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: 12356867
• Report Number: 2648035-2021-08231
• Device Sequence Number: 4535235
• Product Code: HQL
• UDI-Device Identifier: 05050474528963
• UDI-Public: (01)05050474528963(17)260206
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 10/15/2021

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: 02/06/2026
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR