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

Model Number	ZCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown, not provided.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Device evaluation: product evaluation was not performed because the product has not been received.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that one file for handling problem, haptic detached, iol partially delivered and stuck in cartridge was found.Although these complaint issues reported are related; the issues could not be confirmed.Therefore, no escalations are required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) had haptic broke in the cartridge while being injected in the patient's left eye.Lens did touch the patient.Lens was cut out with no damage and was replaced.No vitrectomy, sutures, enlarged incision, and no capsule tear.No post-op injuries are reported and a new lens was implanted.No other information was provided.
Additional Manufacturer Narrative
Additional information: new information received that date of event was (b)(6) 2020.Therefore, updated section b3: date of event : (b)(6) 2020.Section d9.Device available for evaluation? yes returned to manufacturer on: 2/26/2021 section h3.Device returned to manufacturer? yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half (not separated), which is consistent with a lens that was handled during removal and replacement.A detached haptic was also observed, which can be attributed to handling and cannot be confirmed to be related to manufacturing.Based on the return condition of the lens no further evaluation could be performed.The complaint issue could not be confirmed and no product deficiency could be identified.Conclusion: as a result of the investigation there is no indication of a product quality 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: section h6: as part of an internal review of our mdrs it was identified that the code 4631 for device removal and replacement was missing from the initial report.Section h6, health effect - impact code : 4631- device removal and replacement all pertinent information available to johnson and 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 ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11325761
• Report Number: 2648035-2021-07260
• Device Sequence Number: 4140077
• Product Code: HQL
• UDI-Device Identifier: 05050474531598
• UDI-Public: (01)05050474531598(17)220829
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2022

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: 08/29/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 03/10/2021; 10/18/2022
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 04/07/2021; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2018
• 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: Unknown