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

Model Number DCB00

Device Problems Mechanical Jam (2983); Operating System Becomes Nonfunctional (2996); Scratched Material (3020); Ejection Problem (4009)

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

Event Type  malfunction  

Manufacturer Narrative

A5: ethnicity: unknown, information was requested but not provided.B3: date of event: exact date is unknown/not provided.Best estimate date is on or prior to (b)(3) 2023.D6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.D6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section h3-other (81): the device was not returned for evaluation as it was discarded.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 were made to obtain the missing information; however, the information was not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the monofocal intraocular lens (iol) was damaged due to faulty cartridge.The doctor indicated that the lens was scratched by the lens inserter/plunger upon insertion.The cartridge did not work as it should and the haptic caught on the inserter while injecting.The lens was removed from the patient¿s left eye and another johnson & johnson lens with the same model and diopter implanted.It was indicated that balanced salt solution used was at room temperature.After inserter prep, there were no delays in the surgery before an attempt was made to advance the lens and the lens was not positioned closer to the tip of the cartridge than normal.No damage to the cartridge noted and the lens was not stuck in the cartridge.No surgical interventions took place and no patient injury reported.No complications noted/documented upon immediate discharge and care of the patient at the surgery center.The lens was not saved as it was explanted in pieces.No further information was provided.

Manufacturer Narrative

Corrected data: in review, it was noted that the following information was inadvertently not entered in the follow-up mdr report # 1; therefore, the information has been captured in this supplemental mdr report accordingly: a customer photo was provided and evaluated.The photo displays the suspect lens inside the patient's eye, and scratches can be observed on the lens.The following additional code was updated accordingly: section h6: type of investigation: 4112 - analysis of information provided by user/third party.Additional information: the complaint issue "delivery issue" and "plunger rod issue" 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: although the account reported that the "lens was not saved" and the code "4115" was used in the initial mdr report; however, the device was later returned to johnson & johnson for evaluation.Therefore, the following code is no longer applicable: section h6: type of investigation: 4115 - device discarded additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: jan 26, 2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: product evaluation was performed under magnification.The complaint device presented with stress marks in the neck of the cartridge and cartridge tip.The cartridge tip was also observed to be damaged/deformed.The lens module was inspected for markings that would indicate the plunger rod improperly advanced and none were identified.The handpiece assembly was inspected and no issues were identified.The lens was received coated in viscoelastic residue and cut in half.The lens was cleaned and presented with scratches, and damage to the lens as well as the haptics.The complaint issue of "cosmetic issues" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The complaint issues "stuck in cartridge and plunger rod issue" were not confirmed during product evaluation.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.

Manufacturer Narrative

Corrected data: in review, it was noticed that an incorrect medical device problem code "2983" was inadvertently entered in section "h6" of the initial mdr report; therefore, this supplemental mdr is to correct that information and the following field was updated accordingly: section h6: medical device problem code: 4009 - ejection problem.The following code no longer is applicable: section h6: medical device problem code: 2983 - mechanical jam.All pertinent information available to johnson and 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: 18370487
• MDR Text Key: 331079602
• Report Number: 3012236936-2023-03227
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636071
• UDI-Public: (01)05050474636071(17)260111
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000195
• 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: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2023
• 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
• Treatment: BALANCED SALT SOLUTION
• Patient Sex: Female
• Patient Weight: 129 KG
• Patient Race: White