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

Model Number	DIU150
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Ejection Problem (4009)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: unknown; requested but not provided.Race and ethnicity: unknown; requested but not provided.If implanted, give date: unknown, information was requested but not provided.If explanted, give date: not applicable, as the lens remains implanted.Other (81): the device was not returned for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint history for production order for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during implantation of the preloaded intraocular lens (iol), the trailing haptic was not folded on top of the optic.Instead, it was stuck to the plunger rod and as the surgeon was manipulating the lens to get it off of the inserter, the leading haptic tore a hole in the capsular bag.No reported vitreous came forward.The lens was fully inserted and left in the correct position in the eye.Miochol-e was used in surgery and the patient was instructed to lay flat for one hour post-operative.The patient was checked a few hours later and the visual acuity was fine and capsular bag hole remains stable.No further information was provided.
Additional Manufacturer Narrative
The product was returned to the manufacturing site for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: may 16, 2024.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection of the complaint device revealed that the plunger rod was fully advanced.The plunger rod tip presented with damage consistent with damage that occurs during shipping.Viscoelastic residue was distributed through the length of the cartridge.The lens module was inspected, presenting with no damage, however, viscoelastic residue was identified.Device assembly was inspected, and no issues were identified; however, viscoelastic residue was below the lens module indicating that an excessive amount could have been used which may have contributed to complaint event.No lens was received.The complaint issues were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19186701
• Report Number: 3012236936-2024-01237
• Device Sequence Number: 18000100
• Product Code: MJP
• UDI-Device Identifier: 05050474746589
• UDI-Public: (01)05050474746589(17)250917
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2025
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male