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

Model Number	ZA9003
Medical Device Problem Codes	Break (1069); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight and ethnicity: unknown, information not provided.If implanted, give date: not applicable, as there is no indication that the lens was implanted if explanted, give date: not applicable, as there is no indication that the lens was implanted therefore it was not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a za9003 model intraocular lens(iol) had haptic bent upon insertion into the patient's left eye.The lens was partially inserted and removed in the same procedure.No medical/ surgical interventions such as incision enlargement, vitrectomy or sutures were not done.There was no delay in procedure reported.The issue did not significantly affect patient's daily activities and the patient has fully recovered.No further information available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation ¿ yes, returned to manufacturer on 11/11/2021 section h3: device evaluated by manufacturer ¿ yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the inside of the cartridge.Further inspection revealed that the lens was received stuck in the cartridge.The lens was removed form the cartridge, but it came out in pieces and one haptic was not found.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 specification.A search revealed that no additional complaint was received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12678352
• Report Number: 2020664-2021-07837
• Device Sequence Number: 11803593
• Product Code: HQL
• UDI-Device Identifier: 05050474529120
• UDI-Public: (01)05050474529120(17)241213
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

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: 12/13/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female