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

Model Number	ZA9003
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lens was partially inserted and removed during the same procedure, as the trailing haptic broke off in the patient¿s right eye.There was a 5-minute delay in the procedure.There were no surgical and/or medical interventions and no patient injury reported.The patient has fully recovered.No further information was provided.
Additional Manufacturer Narrative
Give date: n/a (not applicable).There is no indication that the intraocular lens was implanted.If explanted, give date: n/a (not applicable).There is no indication that the intraocular lens was implanted.Therefore, lens was not explanted.Device evaluated by mfr: other (81): the lens was not returned for evaluation as it remains implanted in the eye.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.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: nov 7, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside of the original lens case.The original folding carton, patient stickers, and a folding cartridge were received as well.Additional information on a note card was received as well.Visual inspection under magnification revealed that the complaint lens was receive cut in half and with a haptic detached.The lens was cleaned and no further issues were identified with the lens.Based on the return condition of the lens, no further product evaluation could be performed.Conclusion: the complaint issue "haptic detached" was observed 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.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information from the account indicated that an emerald cartridge was used, but they did not have the lot number.Additionally, it was stated that the procedure was completed with the backup za9003, 25.0 diopter.The patient is white, 380lbs.The following fields were unpdated accordingly: b5: the procedure was completed with the backup za9003, 25.0 diopter.A4: patient weight: 380lbs.A5: race: white.D10: concomitant medical products and therapy dates: emerald cartridge, lot unknown.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: 15749466
• Report Number: 3012236936-2022-02774
• Device Sequence Number: 15031975
• Product Code: HQL
• UDI-Device Identifier: 05050474529113
• UDI-Public: (01)05050474529113(17)270421
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030250
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 11/08/2022; 12/01/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 11/08/2022; 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE, MODEL/LOT: UNKNOWN.; EMERALD CARTRIDGE, LOT UNKNOWN.
• Patient Sex: Female
• Patient Weight: 172 KG
• Patient Race: White