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

Model Number	ZA9003
Medical Device Problem Codes	Material Fragmentation (1261); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's left eye.It was learned that the haptic of the iol lost during insertion.Further information noted that the trailing haptic detached after the optic left the injector and was already in the eye.The case was very complicated (posterior synechiae/poor dilation requiring malyugin ring; loose zonules /capsular bag requiring a capsular tension ring; very dense cataract) - as a result, the doctor made the decision to leave the defective lens in and not cause further trauma at that time by cutting out the lens.The doctor wanted to see how she did and see if the lens would remain centered.Unfortunately, it did not and decentered inferiorly causing blurry vision.Therefore, iol exchange was done.Original plan was to replace with another za9003 but loading that lens proved to be difficult (even with a very experienced tech) and there was concern the same thing would happen again.Therefore, the doctor switched to a non-johnson & johnson 3-piece lens of +24.5 diopter.The patient is doing well.No other information was provided.
Additional Manufacturer Narrative
Section a5 (ethnicity): unknown/ not provided.Asku.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.Section h6: health effect clinical code: 4581 (device decentered or dislocated or tilted subluxated or wrong position and eye anatomy issue).Attempts have been made to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes, returned to manufacturer on: aug.2, 2023.Section h3.Device evaluated manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the complaint lens was received cut in half and with both haptics detached.A piece of one haptic remained in the haptic insert, the other was missing.The lens was cleaned and, no issues further issues could be identified.The lens was sent to añasco for drill hole measurement.Both drill holes passed dimensional inspection.The complaint issue " dc-haptic detached" 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 issue of ¿dc-instability of device after implantation¿ was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation the complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 17087762
• Report Number: 3012236936-2023-01367
• Device Sequence Number: 20351220
• Product Code: HQL
• UDI-Device Identifier: 05050474529106
• UDI-Public: (01)05050474529106(17)260413
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2026
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: Asian