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

Model Number	Z9002
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a z9002 intraocular lens (iol) had a loading error, the lens was damaged during load and doctor wanted a new lens.There was contact with cartridge tip and haptic/optic with eye.No other information was provided.
Additional Manufacturer Narrative
Additional information; section d9: device available for evaluation: yes section d9: returned to manufacturer on: 3/16/2021 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 loading.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 for the product were reviewed.The product was manufactured and released according to specifications.No non conformance/ exception report (nc/er) was found as part of this manufacturing records review.Historical data analysis: the search 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 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: 11408861
• Report Number: 2648035-2021-07345
• Device Sequence Number: 14360309
• Product Code: HQL
• UDI-Device Identifier: 05050474530713
• UDI-Public: (01)05050474530713(17)251202
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: 12/02/2025
• Device Model Number: Z9002
• Device Catalogue Number: Z900200210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL/LOT # UNKNOWN; CARTRIDGE MODEL/LOT # UNKNOWN