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

Model Number	Z9002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Eye Injury (1845); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or date of birth, weight, and ethnicity: unknown, information not provided.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that one additional complaint was received from this production order, however, the complaint issue reported could not be confirmed and no escalations were required.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the surgeon attempted to implant a intraocular lens (iol) into patient's operative eye, however, exchanged it as he noticed the haptic was cracked through the microscope.Another lens was used as the replacement with no other problem.No further information was available.
Additional Manufacturer Narrative
Additional information: section a2: age/date of birth: (b)(6) 1952.Section a3: gender: female.Section b1: report type: adverse event.Section b5: additional information received revealed that the eye affected was left.The original lens was carefully cut out using an additional syringe of viscoelastic during the same procedure and another lens of same model and diopter (sn (b)(6)) was used as the replacement.The patient had mild corneal endothelial trauma.No further information was available.Section h1: type of reportable event: serious injury.Section h6: health effect - clinical code: 1845- eye injury.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Additional information received revealed that the eye affected was left.The original lens was carefully cut out using an additional syringe of viscoelastic during the same procedure and another lens of same model and diopter (sn (b)(6)) was used as the replacement.The patient had mild corneal endothelial trauma.No further information was available.

• Brand Name: TECNIS CL IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12595163
• Report Number: 2020664-2021-07665
• Device Sequence Number: 4460619
• Product Code: HQL
• UDI-Device Identifier: 05050474530690
• UDI-Public: (01)05050474530690(17)260527
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 05/27/2026
• Device Model Number: Z9002
• Device Catalogue Number: Z900200200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PSCST30, LOT: CJ13736
• Outcome Attributed to Adverse Event: Other