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

Model Number	Z9002
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight, and ethnicity: unknown, not provided.If implanted, give date: not applicable, as lens was not implanted.If explanted, give date: not applicable, as lens was not implanted.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that the doctor advanced a z9002 intraocular lens (iol), the top haptic which was in the groove did not move and was sheared off while trying to implant.It was indicated that the lens was opened but not implanted.No other information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review of the file, it was noted that in the initial report (mdr # 2648035-2021-07990) section h6 (medical device problem code) should have included code 2983 to capture lens stuck in cartridge.Therefore, this supplemental filing is correcting the information by providing device problem code 2983 in section h6.Section h6-medical device problem code: 2983.Additional information: 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 for evaluation.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics which is consistent with a lens that was handled during insertion.Furthermore, a detached haptic and lens damage (crack on optic body) was observed, however this can be attributed to handling during insertion.Haptic detached was confirmed however this can be attributed to handling during insertion and cannot be confirmed to be related to manufacturing and therefore no product deficiency could be identified.Stuck in cartridge could not be confirmed because the lens was received outside the cartridge tip.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.

• 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: 11980006
• Report Number: 2648035-2021-07990
• Device Sequence Number: 17207631
• Product Code: HQL
• UDI-Device Identifier: 05050474530522
• UDI-Public: (01)05050474530522(17)251210
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: 12/10/2025
• Device Model Number: Z9002
• Device Catalogue Number: Z900200115
• 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: 05/11/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1