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

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a preloaded intraocular lens (iol) product was defective during the loading process.The iol did not touch the patient's eye.Surgeon used the back-up iol.It was noted that there had been an issues with it/ with advancing it.The circulator documented that the first lens was broken/does not work.There was resistance when advancing it.The original lens was wasted for being defective.The patient recovered and went home without any complications.No other information was provided.
Additional Manufacturer Narrative
Section a6: not applicable/ device did not touch the patient's eye.Section d6a: if implanted, give date: not applicable, as no indication that device was implanted.Section d6b: if explanted, give date: not applicable, as no indication that device was implanted, hence not explanted.Section h3- no: 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.Attempts have 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.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes section d9: returned to manufacturer on: dec 18, 2024 section h3: device evaluated by manufacturer: yes device evaluation: a visual inspection revealed the device was received with the plunger rod fully retracted and with the lens stuck in the mouth of the cartridge.The lens was rotated partially counter clockwise, and a haptic could be observed to be detached.Viscoelastic residue could not be observed in the cartridge.The lens module was inspected revealing no damage or viscoelastic residue.Device assembly was inspected and presented with no assembly issues; however, the plunger rod tip could be observed to be damaged.Plunger rod advancement was inspected and presented with no issues.The lens was removed from the cartridge, presenting torn at the base of the haptic and with cosmetic scratches.The reported complaint issues of "device advancement issue" and "lens damaged" were not identified during product evaluation.The observed "stuck in cartridge" and "cosmetic issues" are similar to the reported complaint issues.However, based on the complaint investigation results the complaint and observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Historical review: a search of complaints related to this production order (po) was performed.The search revealed two additional complaint folders were received for this po.However, complaint issues reported are not related.Therefore, no further actions are required.Conclusion: based on the investigation, no malfunction or product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 20839109
• Report Number: 3012236936-2024-000325
• Device Sequence Number: 3838429
• Product Code: HQL
• UDI-Device Identifier: 05050474731820
• UDI-Public: (01)05050474731820(17)261113
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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 Model Number: DIB00
• Device Catalogue Number: DIB00U0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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