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

Model Number DIB00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Eye Injury (1845)

Event Date 03/26/2024

Event Type  Injury  

Event Description

It was reported that the preloaded intraocular lens (iol) was implanted in the patient's left eye and vitrectomy occurred.The lens was cut out in the same procedure and vitrectomy was performed and three piece new non jnj iol was inserted.From additional information it was learnt that the lens was removed in order to perform vitrectomy safely.There was issue with duovisc (viscoelastic).The patient was discharged in a stable condition.There was no medical/surgical intervention required.There was no use error.No other information is available.

Manufacturer Narrative

Unknown/ asked but not available.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 04/22/2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection of the suspect product revealed there was damage present on the plunger rod tip that could be attributed to damage that occurred during shipping.The cartridge was presented with viscoelastic residue dispersed through the length of the cartridge.The lens module was inspected and no damaged or viscoelastic residue was present.The lens present cosmetic damaged to the optic body and haptics.No further evaluation was performed.The complaint issue "hm-unspecified injury", "pt-unplanned vitrectomy", and "pt-removal and replacement " were not identified during product 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 SIMPLICITY
• Type of Device: 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: 19127232
• MDR Text Key: 340408644
• Report Number: 3012236936-2024-01122
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474731769
• UDI-Public: (01)05050474731769(17)260503
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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?: No
• Device Operator: Health Professional
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 55 KG