MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLCTY TECNIS SYMF ERV OB; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	DXR00V
Medical Device Problem Codes	Break (1069); Difficult to Fold, Unfold or Collapse (1254); Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a4, a5: unknown/ not provided.Asku.Section b3: date of event: unknown, not provided.Asku.Section d6a: if implanted, give date: not applicable, as no indication that lens was implanted.Section d6b: if explanted, give date: not applicable, as no indication that lens was implanted, hence not explanted.Section h3-other (81): the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt has been made to obtain missing information; however, no definitive response has been received.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) was partially inserted, broken haptic when inserting into the patient's operative eye.Trailing haptic was not folded.He tried to pull the plunger back and that is when the haptic broke.Main issue is that, trailing haptic was not folded.Back-up iol implanted, no patient injury, patient is fine.No capsule tear, no incision enlargement, no vitrectomy, no sutures done.No other information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Returned to manufacturer on apr.22, 2024.Section h3: device evaluated manufacturer? yes.Device evaluation: visual inspection was performed on the suspect product and found a portion of the lens could be observed to be in the cartridge and override by the plunger rod.The lens module was inspected with no damaged however viscoelastic residue was identified.The portion of the lens was attempted to be removed but was in pieces and haptic was detached.Customer photos were evaluated.The photo displays the lens module with the lens.The lens was observed to be cut in half with a missing haptic.No damage was observed on the lens module.No further evaluation was performed.The complaint issue "dc-delivery issue", "dc-trailing haptic not folded" and "dc-haptic damaged" were not identified during product and photo evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation, there was no product deficiency or product malfunction that could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLCTY TECNIS SYMF ERV OB
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 19081594
• Report Number: 3012236936-2024-01099
• Device Sequence Number: 20743423
• Product Code: POE
• UDI-Device Identifier: 05050474761872
• UDI-Public: (01)05050474761872(17)251024
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/15/2024

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: 10/24/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU240
• 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: 05/15/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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
• Patient Sex: Unknown