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

Model Number	AR40E
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight and ethnicity: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Implant date: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Explant date: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Initial reporter name and address - telephone number: (b)(6).Device evaluated by mfr: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the haptics of the intraocular lens (iol) did not unfold post implantation in the patient's surgical eye.The lens was implanted and removed during the same procedure after the surgeon realized that the iol was not unfolding correctly.The procedure was completed successfully, no further medical or surgical intervention was required.No further information provided.
Additional Manufacturer Narrative
Additional information: new information received that came in with product return.Patient female, 71 yrs.Old, date of birth (b)(6); fields below updated: section a2: age and date of birth: 71 yrs.Old, (b)(6).Section a3: gender; female.Section d9 - device available for evaluation? yes section d9 - date returned to manufacturer: 21st june 2022.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the lens was received with one haptic detached and the other haptic was received bent.The lens was cleaned and a cut to the optic body as well as a crease in the lens were observed.Scratches on the optic body could also be observed.The complaint issue of unfolding issue could not be confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR 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: 14632212
• Report Number: 3012236936-2022-01509
• Device Sequence Number: 20313052
• Product Code: HQL
• UDI-Device Identifier: 05050474502161
• UDI-Public: (01)05050474502161(17)260927
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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 Expiration Date: 09/27/2026
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00230
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Female