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

Model Number ZA9003

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problems Retinal Detachment (2047); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

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.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that after fully inserting an intraocular lens (iol) into a patient¿s right eye, the surgeon noticed that the lens was rippled and did not like position of the lens.The surgeon used steinert ii lens folding forceps to remove the lens.Posted procedure done were indicated to be 25 gauge vitrectomy, intraocular lens exchange, and endolaser.A non-johnson and johnson lens of 23.5 diopter was used as a replacement.The procedure completed successfully with no patient injury reported.No medical interventions required.The patient tolerated procedure well and was transported to post anesthesia care unit (pacu).Additional information received confirmed that there was no capsule tear, the vitrectomy was planned which was performed during this same procedure.It was noted that the surgeon's operational note indicated that "inspection of the retina under the resight viewing system revealed an already present posterior vitreous detachment.The endolaser was used for the detachment." this was completed prior to lens exchange.

Manufacturer Narrative

Additional information/corrected data: in review, based on the additional information received from the customer which indicated that the posterior vitreous detachment happened prior to cataract surgery, it was determined that the "health effect ¿ ¿clinical code 2047 - retinal detachment & health effect - impact code 4624 - surgical intervention" no longer applies, and instead the "health effect - clinical code 4582" is applicable to this event.Also, in review of the additional information, the event is no longer considered to be an "adverse event"; therefore, sections "b1-adverse event & b2- required intervention to prevent permanent impairment/damage (devices)" are no longer applicable; therefore, this event is only a "malfunction" case.The following fields were updated accordingly: section h1: type of reportable event: malfunction section h6: health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Additional information: section b5: the affected eye was the left eye.Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: apr 5, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside of the original folding carton.Patient stickers, a patient identification (id) card, the original lens case, and additional documentation.Visual inspection under magnification revealed that the complaint lens was received cut and a haptic was damaged (severed).The lens was cleaned and, no additional issues were observed with the lens.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue of ¿positioning issue and lens damaged¿ were not confirmed.The observed "haptic damaged" is similar to the reported complaint issue of lens damaged.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.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 left eye was inadvertently indicated as the affected eye in the supplemental mdr report #1 which is incorrect; therefore, the information has been corrected in this supplemental mdr report and the following field was updated accordingly: section b5: the affected eye was the right eye.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS IOL
• 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: 16685897
• MDR Text Key: 312756285
• Report Number: 3012236936-2023-00835
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529090
• UDI-Public: (01)05050474529090(17)271126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990080
• 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
• Report Date: 04/30/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030240
• 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: 03/08/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 04/05/2023; 04/28/2023
• Supplement Dates FDA Received: 04/29/2023; 04/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2022
• 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: PROVISC
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native