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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4, a5: unknown/ not provided.Asku.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Device evaluation: product evaluation was not performed because the product has not been returned.The complaint issue reported could not be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed one additional complaint folder was received for this po.However, complaint issues reported are not related.Therefore, no escalations are required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.Section h6: health effect impact code: 4625 (pt- unplanned vitrectomy).An attempt has been made to obtain missing information; however, however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was fully inserted in the patient's left eye, but had bent/broken haptic, vitrectomy performed.The suspect iol was removed and replaced with the back-up iol of the same model and same diopter size.The issue did not significantly affect patient¿s daily activities.Patient outcome unknown.No other information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: jul.20, 2023.Section h3.Device evaluated manufacturer? yes.Device evaluation: the suspect iol was received with a detached haptic.The detached haptic was also bent.No further issues with the iol were observed.The iol was forwarded to the manufacturing site in anasco, pr for drill hole measurements.The subject matter expert (sme) analysis concluded that the drill holes were within specification.The complaint issue "haptic damage" 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.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there is no product deficiency or product malfunction that 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: 16981354
• Report Number: 3012236936-2023-01072
• Device Sequence Number: 15146555
• Product Code: HQL
• UDI-Device Identifier: 05050474529069
• UDI-Public: (01)05050474529069(17)261107
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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 Model Number: ZA9003
• Device Catalogue Number: ZA90030225
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2021
• 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: Male