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

Model Number DIU150

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

Section a, patient information: a4, a5: information unknown/asku.Section d6a, if implanted, give date: not applicable.There is no indication the lens was implanted.Section d6b, if explanted, give date: not applicable.There's no indication the lens was implanted.Hence, not explanted.Section e1, telephone number: (b)(6).Entering the telephone number in h10 as the field only takes the us format.Section h3-other (81): the device has not been 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 the missing information.However, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported the johnson and johnson(jnj) intraocular lens (iol) was damaged.When advancing the plunger it passed beside the lens (overrode lens), pressing and locking the iol in the internal mechanism of the preloaded device.As a result, the iol was damaged in the central optic and haptics, requiring replacement.The iol was not inserted into the eye as it was stuck in the syringe and the lens was damaged.The procedure was completed with another jnj iol of the same model.The postoperative period was uneventful.No further information was provided.

Manufacturer Narrative

Additional information.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: dec 4, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside the original folding carton.The complaint simplicity was visually inspected under magnification.It was observed that the simplicity was received disassembled with the lens module broken.Ovd was observed to be disbursed throughout the cartridge and inside the lens module, which indicated that an excessive amount of ovd was used.The lens received outside of the simplicity and was observed to be coated in viscoelastic residue, the lens was cleaned, and damage and scratches were observed on the surface and edges of the lens.No further issues were 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.

• Brand Name: TECNIS IOL
• Type of Device: 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: 17096190
• MDR Text Key: 316929497
• Report Number: 3012236936-2023-01373
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474726468
• UDI-Public: (01)05050474726468(17)260114
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIU150
• Device Catalogue Number: DIU150I220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2023
• 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 Age: 64 YR
• Patient Sex: Male