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	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the tecnis intraocular lens (iol) was fully inserted, but had to be replaced due to a bent/broken haptic.There was patient involvement and no injury reported.Patient has recovered.No further information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Section d9: return to manufacturer: 8/25/2021 section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site.Visual inspection under magnification revealed two parts of an iol (another part missing).Viscoelastic residue was found on the optic body and haptic, which is consistent with a lens that was handled during removal.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and 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 specifications.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data and additional information: additional information received with the product return revealed the physician's name and patient's date of birth that were not captured in the initial medwatch report# 2648035-2021-08296.The following fields have been updated: section a2: date of birth: (b)(6) 1947 section e1: complaint reporter first and last name: omar hanuch section e2: health professional = yes section e3: occupation: physician 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: 12321298
• Report Number: 2648035-2021-08296
• Device Sequence Number: 19583743
• Product Code: HQL
• UDI-Device Identifier: 05050474528970
• UDI-Public: (01)05050474528970(17)250227
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/27/2021

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: 02/27/2025
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 09/16/2021; 09/27/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/23/2021; 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR